Clinical practice guideline forcolonic fecal retention
assessment during constipation
for nursing care: Japan edition

Supervised by the Japan Academy of Nursing Science
Edited by the Nursing Care Development/Standardization Committee

2023 Edition

Clinical practice guideline for colonic fecal
retention assessment during constipation for
nursing care(English version 2023)

JANS
Supervised by the Japan Academy of Nursing Science
Edited by the Nursing Care Development/Standardization Committee

2023 Edition

Preface

In 2017, the Japan Academy of Nursing Science, a public interest incorporated association, establishedthe Nursing Care Development and Standardization Committee with the mandate to establish a system totranslate nursing research evidence into clinical practice, under the stewardship of then-President Yayoi
Kamakura. The first chairperson of the committee was Hiromi Sanada (President for 2019–2020), who
was succeeded by Junko Sugama in 2019.
The first model project of this committee was the development of “Clinical Practice Guideline for
Aspiration and Pharyngeal Residual Assessment during Eating and Swallowing for Nursing Care.” This was
the first guideline development effort by the Japan Academy of Nursing Science, and adhering to the“Minds Practice Guideline Development Manual 2017,” a steering committee, a guideline developmentgroup, and a systematic review team were formed to carry out the work. Since many aspects were notexplicitly stated in the manual, the work proceeded through an in-depth review of technical books regarding guideline formulation, video tutorials, and consultation with experts in guideline development, and it
took approximately two and a half years from the start to publication.
This “Clinical Practice Guideline for Colonic Fecal Retention Assessment during Constipation for
Nursing Care” is the second guideline to be published. The guideline development protocol was compliant
with the “Minds Medical Practice Guideline Development Manual 2020 ver. 3.0.” Benefiting from theexperience of previous guideline formulation, the process was completed in a considerably shorter time of
approximately 1 year and 8 months. This medical practice guideline was also adopted by the Japan Agency
for Medical Research and Development (AMED) for research on the creation of Medical Arts (development of new medical technologies and software for surgery, oncology, nursing, rehabilitation, etc.) field 1
Medical Technology Development, which was conducted from FY2016 to FY2018, and was entitled“Advanced Nursing Technology Construction of a Multidisciplinary Cooperative System to Support Eating, Swallowing, and Defecation of Patients Treated at Home and in Nursing Facilities by Introducing
Advanced Nursing Technology (Principal Investigator: Hiromi Sanada, Professor Emeritus, University ofTokyo; President, Ishikawa Prefectural College of Nursing).”
The formulation of clinical practice guideline for the assessment of aspiration and pharyngeal residual
assessment and the assessment of colonic fecal retention has enabled standardization of nursing care related
to eating and defecation. We believe this is a tangible step toward translating research evidence into clinicalpractice, which was the goal of establishing the committee. Further research is required to identify the best
approach for implementing and disseminating standardized assessments.
We would like to express our sincere gratitude to the members of the guideline development steeringcommittee, the guideline development group, the systematic review team, and the panel that determinedthe degree of recommendation, to have patiently provided guidance and encouragement over a long period― ii ―

during the development of this guideline. We would also like to express our sincere appreciation to all
external committee members for their dedication to this project. We thank Shigeko Horiuchi, President of
the Japan Academy of Nursing Science, the board of directors, the auditors, the external reviewers who
reviewed the report before its publication and provided advice, and the members of the Japan Academy of
Nursing Science who provided their invaluable inputs in the guideline development group. We would also
like to thank Takayuki Arita, Director of the Office of the Japanese Society of Nursing Science, and thestaff for their administrative support during the process of preparing and publishing this guideline.
We hope that this guideline will help improve the quality of defecation care for subjects who are notalways able to communicate their discomfort and needs regarding defecation.
May 2023
Chairperson of the Nursing Care Development /Standardization Committee

Junko Sugama― iii ―

Contents
Preface …………………………………………………………………………………………………………ii
Clinical question and recommendation ………………………………………………………………ix

Executive summary ………………………………………………………………………………………1
1．Title ………………………………………………………………………………………………………2
2．Purpose …………………………………………………………………………………………………2
3．Scope ……………………………………………………………………………………………………2
4．Target patients…………………………………………………………………………………………2
5．Target audience ………………………………………………………………………………………3
6．Constituent organizations …………………………………………………………………………3
7．Organization members and roles …………………………………………………………………5
1) Guideline development steering committee ………………………………………………52) Guideline development group ………………………………………………………………53) Systematic review team…………………………………………………………………………64) Panel members ……………………………………………………………………………………75) Cooperative member ……………………………………………………………………………76) Secretariat …………………………………………………………………………………………77) External evaluation committee ………………………………………………………………88．Conflicts of interest (COI) …………………………………………………………………………8
9．Guideline development process …………………………………………………………………91) Development policy ……………………………………………………………………………92) Development process …………………………………………………………………………9(1) Organizational structure for creation …………………………………………………9(2) Scoping ……………………………………………………………………………………11(3) Systematic review ………………………………………………………………………11(4) Creation of recommendations ………………………………………………………12(5) Finalization …………………………………………………………………………………13
10．Clinical question and summary of recommendation ……………………………………14
1) Assessments covered by the guidelines …………………………………………………14
2) List of CQs and recommendations …………………………………………………………14― iv ―

Contents

11．Glossary ……………………………………………………………………………………………18
1) Important term …………………………………………………………………………………18
2) List of abbreviations ……………………………………………………………………………18
12．Scope of coverage and focus of the guideline ……………………………………………18
13．Relationship to existing guidelines ……………………………………………………………19
14．Results of external evaluation and reflection in guidelines ……………………………19
15．MINDS preliminary evaluation and reflection in guidelines ……………………………20
16．Public comments and reflection in guidelines ……………………………………………23
17．Funds …………………………………………………………………………………………………23
18．Audit Standards ……………………………………………………………………………………24
19．Dissemination and implementation of the guideline ……………………………………24
20．Post-publication efforts …………………………………………………………………………24
1) Organizational structure after release ……………………………………………………24
2) Efficacy evaluation and monitoring…………………………………………………………24
3) Revision cycle ……………………………………………………………………………………24

Part 1．Constipation ……………………………………………………………………………………27
1．Clinical characteristics ……………………………………………………………………………28
1) Definition …………………………………………………………………………………………28
2) Classification ……………………………………………………………………………………28
3) Pathophysiology of constipation ……………………………………………………………29
4) Anatomy and functions of defecation ……………………………………………………29
5) Diagnosis …………………………………………………………………………………………31
2．Epidemiological characteristics …………………………………………………………………32
3．Constipation assessment …………………………………………………………………………33
1) Assessment and nursing care objectives and methods ………………………………33
2) Algorithm for assessment-based nursing care …………………………………………34
3) Assessment methodology ……………………………………………………………………36(1) Interview ……………………………………………………………………………………36(2) Defecation diary …………………………………………………………………………36(3) Assessment of stool form, volume, etc. ……………………………………………37(4) Self-assessment chart for the presence and severity of constipation ………38(5) Quality of life assessment ………………………………………………………………39(6) Physical examination ……………………………………………………………………40(7) Rectal and anal visual examination, perianal palpation, and rectal andanal digital examination…………………………………………………………………41(8) Ultrasonography …………………………………………………………………………41―v―

4．Assessment-based nursing care …………………………………………………………………43
1) Care to promote stool mass discharge……………………………………………………43(1) Digital impaction …………………………………………………………………………43(2) Enema, suppository………………………………………………………………………43(3) Biofeedback ………………………………………………………………………………43(4) Pelvic floor muscle exercises …………………………………………………………44(5) Transanal irrigation ………………………………………………………………………44
2) Care to promote intestinal peristalsis ……………………………………………………44(1) Lifestyle modification ……………………………………………………………………44
3) Diet modification and pharmacotherapy …………………………………………………45(1) Diet modification …………………………………………………………………………45(2) Probiotics …………………………………………………………………………………45(3) Pharmacotherapy…………………………………………………………………………45

Part 2．Recommendation statements and systematic reviews for each CQ ……49
1．CQ 1 ……………………………………………………………………………………………………50
1) Recommendation ………………………………………………………………………………50
2) Background and aims …………………………………………………………………………50
3) Commentary ……………………………………………………………………………………50
4) Database search results ………………………………………………………………………51
5) Literature search flowchart …………………………………………………………………52
2．CQ 2 ……………………………………………………………………………………………………53
1) Recommendation ………………………………………………………………………………53
2) Background and aims …………………………………………………………………………53
3) Commentary ……………………………………………………………………………………53
4) Database search results ………………………………………………………………………53
5) Literature search flowchart …………………………………………………………………54
3．CQ 3 ……………………………………………………………………………………………………55
1) Recommendation ………………………………………………………………………………55
2) Background and aims …………………………………………………………………………55
3) Commentary ……………………………………………………………………………………55
4) Database search results ………………………………………………………………………56
5) Literature search flowchart …………………………………………………………………57
4．CQ 4 ……………………………………………………………………………………………………58
1) Recommendation ………………………………………………………………………………58
2) Background and aims …………………………………………………………………………58
3) Commentary ……………………………………………………………………………………58― vi ―

Contents

4) Database search results ………………………………………………………………………60
5) Literature search flowchart …………………………………………………………………61
6) Reference standards: BSFS, defecation cycle, digital impaction ……………………62
7) Reference standards: digital impaction, enema, stool form …………………………64
8) Reference standard: Hard stool (BSFS1 or 2) ……………………………………………66
5．CQ 5 ……………………………………………………………………………………………………70
1) Recommendation ………………………………………………………………………………70
2) Background and aims …………………………………………………………………………70
3) Commentary ……………………………………………………………………………………70
4) Database search results ………………………………………………………………………71
5) Literature search flowchart …………………………………………………………………72
6) List after secondary screening ………………………………………………………………72
7) List of included papers ………………………………………………………………………73
8) Evaluation of the evidence in individuar studies ………………………………………73
9) Evaluation of body of evidence ……………………………………………………………73
10) Qualitative systematic review ……………………………………………………………74
6．CQ 6 ……………………………………………………………………………………………………75
1) Recommendation ………………………………………………………………………………75
2) Background and aims …………………………………………………………………………75
3) Commentary ……………………………………………………………………………………75
4) Database search results ………………………………………………………………………76
5) Literature search flowchart …………………………………………………………………76
7．CQ 7 ……………………………………………………………………………………………………77
1) Recommendation ………………………………………………………………………………77
2) Background and aims …………………………………………………………………………77
3) Commentary ……………………………………………………………………………………77
4) Database search results ………………………………………………………………………78
5) Literature search flowchart …………………………………………………………………78
8．CQ 8 ……………………………………………………………………………………………………79
1) Recommendation ………………………………………………………………………………79
2) Background and aims …………………………………………………………………………79
3) Commentary ……………………………………………………………………………………79
4) Database search results ………………………………………………………………………80
5) Literature search flowchart …………………………………………………………………81
6) List after secondary screening ………………………………………………………………82
7) List of included papers ………………………………………………………………………82
8) Evaluation of the evidence in individuar studies ………………………………………83
9) Evaluation of body of evidence ……………………………………………………………87
10) Qualitative systematic review ……………………………………………………………88― vii ―

Appendix ……………………………………………………………………………………………………91
1．Key clinical issues……………………………………………………………………………………92
Key clinical issue 1 …………………………………………………………………………………92
Key clinical issue 2 …………………………………………………………………………………93
Key clinical issue 3 …………………………………………………………………………………94
Key clinical issue 4 …………………………………………………………………………………95
2．Database search formula …………………………………………………………………………96
3．The conflict of interest statuses …………………………………………………………………98― viii ―Clinical question and recommendation
Strength of recommendationstrong1

weak

2

Recommendation by the expert panel—

Overall certainty (strength) of evidence on overall outcomes for recommendation decisions
A (Strong)

Strong confidence in the appropriateness of the effect estimate to support
recommendations

B (Moderate)

Moderate confidence in the appropriateness of the effect estimate to support
recommendations

C (Weak)

Limited confidence in the appropriateness of the effect estimate to support
recommendations

D (Very weak)

Little confidence in the appropriateness of the effect estimate to support
recommendations(Adapted from the Minds Manual for Guideline Development 2020 ver. 3.0., p. 117)

CQ 1
Is a systematic assessment using defecation diaries and interviews useful in the evaluation of
constipation in adult patients who are not always able to communicate their discomfort andneed for defecation?
Recommendation - In adult patients who are not always able to communicate their discomfort
or need for defecation, a systematic assessment using a defecation diary, which is noninvasive,
and a medical interview is recommended.
Recommendation by the expert panel

CQ 2
Is systematic assessment using physical examination techniques (inspection, auscultation,
palpation, and percussion) useful in the evaluation of constipation in adult patients who are notalways able to communicate their discomfort or need for bowel movements?
Recommendation - In adult patients who are not always able to communicate their discomfort
or need for defecation, it is recommended that a systematic assessment be performed using
noninvasive physical examination techniques (inspection, auscultation, palpation, and percussion).
Recommendation by the expert panel

CQ 3
Is assessment by digital rectal examination useful in the evaluation of rectal fecal impaction
during constipation in adult patients who are not always able to communicate their discomfort
or need for defecation?
Recommendation - In adult patients who are not always able to communicate their discomfort
or need for defecation, it is strongly recommended that a digital rectal assessment be performed
to evaluate rectal fecal retention during constipation.
GRADE 1D

― ix ―

CQ 4
Is the assessment of rectal stool retention by ultrasound imaging useful in the evaluation of
constipation in adult patients who are not always able to communicate their discomfort or needfor defecation?
Recommendation - In adult patients who are not always able to communicate their discomfort
or need for defecation, it is strongly recommended that rectal fecal impaction be assessed byultrasound imaging to determine rectal fecal impaction.
GRADE 1CCQ 5
Is defecation care based on systematic assessment using defecation diaries and interviews usefulfor improving patient outcomes in adult patients who are not always able to communicate theirdiscomfort and need regarding defecation?
Recommendation - We propose the implementation of defecation care based on systematic
assessment using defecation diaries and interviews with adult patients who are not always able tocommunicate their discomfort or need regarding defecation.
GRADE 2D

CQ 6
Is defecation care based on systematic assessment using physical examination techniques(inspection, auscultation, palpation, and percussion) useful for improving patient outcomes inadult patients who are not always able to communicate their discomfort or need for defecation?
Recommendation - In adult patients who are not always able to communicate their discomfort orneed for defecation, it is recommended that defecation care be based on systematic assessment using
abdominal physical examination techniques (inspection, auscultation, palpation, and percussion).
Recommendation by the expert panel

CQ 7
Is defecation care based on the assessment by digital rectal examination useful for improving
patient outcomes in adult patients who are not always able to communicate their discomfort orneed for defecation?
Recommendation - Defecation care based on digital rectal examination is strongly recommended
in adult patients who are not always able to communicate their discomfort or need for
defecation.
GRADE 1D

CQ 8
Is defecation care based on observation of rectal stool retention by ultrasound imaging usefulfor improving patient outcomes in adult patients who are not always able to communicate theirdiscomfort and need for defecation?
Recommendation - In adult patients who are not always able to communicate their discomfort
or need for defecation, it is strongly recommended to implement defecation care based on
ultrasound imaging to detect rectal stool retention.
GRADE 1C―x―

Executive summary

1. Title
Clinical practice guideline for colonic fecal retention assessment during constipation for nursing care

2. Purpose
Constipation is a common symptom in the general population. However, in our hyper-aged society, it has
become a chronic health problem.
This guideline aims to provide and recommend methods for the assessment, selection, and implementation ofnursing care for colonic retention during constipation in adults who are not always able to communicate theirdiscomfort or need for defecation. This guideline would enable the nurses to provide appropriate care to alleviate
constipation at an early stage, thus providing patient comfort and preventing serious complications, such as
bowel obstruction, perforation, ulceration, and bleeding. This guideline deals with defecation assessment performed by nurses as part of medical care under the Act on Public Health Nurses, Midwives, and Nurses.
The recommended levels in this guideline are not mandatory and are only a reference document to present
assessment methods in defecation care.

3. Scope
Assessment of colonic fecal retention during constipation in adults

4. Target patients
The target patients are individuals aged over 18 years who are not always able to communicate their discomfort or need for defecation. These include patients with cerebrovascular disease, cerebral dysfunction, impaired
consciousness, dementia, intractable diseases, and terminally-ill patients. Adult patients who require defecation
support, such as patients with spinal cord injury, are also considered targets. Furthermore, these guidelines arealso applicable to those with an elevated rectal sensory threshold due to aging or other factors (rectal sensory
insensitivity) and those who have lost the strong urge to defecate due to continuous defecation suppression.

―2―

5. Target audience
The target audience of this guideline are nurses who provide defecation care in hospitals, long-term care facilities, and homes in collaboration with physicians, pharmacists, physical therapists, occupational therapists, radiology technicians, clinical technologists, care workers, and other professionals.

6. Constituent organizations (Figure 1)
The “Clinical Practice Guideline for Colonic Fecal Retention Assessment for Nursing Care” were developed
under the Japan Academy of Nursing Science (JANS). The following three divisions formed by the “Nursing

Core: Japan Academy of Nursing Science (Public Interest Incorporated Association)
Nursing Care Development/Standardization Committee
Guideline development
steering committee

Guideline development
group

Clariﬁcation of the
purpose of creation

Scope development

Organization

Determination of clinicalquestions based on key
clinical issues

Systematic review team

スコープ
Scope

Development ofrecommendations
Final decision of theguideline

Systematic review

Cooperative
memberSummary report

Panel members
Drafting guideline

Finalization

External evaluationcommittee
Publication

Post-publication eﬀorts

Revision
Secretariat

Figure 1: Organizational structure for developing the clinical practice guideline―3―Care Development/Standardization Committee” were involved in the development of the guideline: the guideline development steering committee, the guideline development group, and the systematic review team.
The guideline development steering committee was formed in October 2021 and comprised experts in nursing technology development, geriatric nursing, imaging nursing, continence care, gastroenterology, home healthcare, and clinical practice guideline development. The guideline development group comprised of experts innursing technology development, geriatric nursing, home care nursing, continence care, imaging nursing, gastroenterology, diagnostic imaging, and guideline development who had the necessary expertise to develop thisguideline. The systematic review team was independent of the guideline development group, and its members
were selected from among the members recommended by the guideline development steering committee andmembers of the JANS based on the selection criteria. The members of the systemic review team were appointed
in December 2021 with the approval of the board of directors. In principle, the minimum criteria for the systematic review team were: a doctoral degree, at least one original research paper in English published as the firstauthor, and experience attending seminars on systematic review or guideline development.
In addition to the three divisions, panel members, cooperating members, secretariat, and external evaluationcommittee members were appointed. In addition to the 10 members of the guideline development group, thepanel members included a Certified Nurse in Wound, Ostomy and Continence Nursing who provides dermatology/ continence care at home, a Certified Nurse in Wound, Ostomy and Continence Nursing affiliated witha hospital with a recovery-phase rehabilitation ward for patients with spinal cord injury and stroke, a faculty
member of a nursing college specializing in the field of psychiatric nursing, and a physician in the department ofpalliative medicine. The cooperating members were a librarian at a nursing college who had the necessary expertise to perform a literature search for the systematic review. The secretariat was a member of the JANS tasked
with managing all organizations involved in the development of the guidelines. These organizations included
non-members of the JANS, who were referred to as external cooperative members. After the completion of thedraft, an external evaluation committee was formed consisting of experts independent of the above organizations. The external evaluation committee were experts recommended by medical societies related to gastroenterological diseases, medical and nursing societies related to excretion, geriatrics and gerontological nursing, andhome health care and home nursing. In addition, the guideline was preliminarily evaluated by Minds.

―4―

7. Organization members and roles
For each member of the clinical practice guideline organization shown in Figure 1, the name, affiliation, location, and role are listed in the table．

1) Guideline development steering committee
Name

Affiliation

LocationRole

Junko Sugama(Chair)Research Center for Implementation Nursing Science
Initiative, Fujita Health University

Toyoake, Aichi

Nursing technology development

MiyukiIshibashi

Graduate School of Nursing, Chiba University

Chiba City, Chiba Gerontological nursing

Shingo Okada* Kitamihara Clinic

Hakodate,
Hokkaido

Home health care

Hiromi Sanada Ishikawa Prefectural Nursing University

Kahoku,Ishikawa

Imaging nursing, Gerontologicalnursing, Continence care

AtsushiNakajima*

Department of Gastroenterology and Hepatology,
Yokohama,
Graduate School of Medicine, Yohokama City University Kanagawa

Gastroenterology

Takeo
Nakayama*

Health Management Course, Kyoto University School of Kyoto City,
Public Health
Kyoto

Expert in creating clinical practiceguidelines

Kaoru
NishimuraContinence Japan Co., Ltd.

Suginami, Tokyo Continence care*: External cooperative members

2) Guideline development group
Name

Location

Role

Junko
Research Center for Implementation Nursing Science
Sugama(leader) Initiative, Fujita Health University

Affiliation

Toyoake, Aichi

Nursing technology development

Nao Tamai (subleader)Department of Nursing, Graduate School of Medicine,
Yokohama City University

Yokohama,
Kanagawa

Imaging nursing

Erika Ota

Global Health Nursing, St. Luke's International
University

Chuo, Tokyo

Expert in creating clinical practiceguidelines

Atsuo
Kawamoto

Department of Radiology, Tokyo Medical University
Hospital

Shinjuku, Tokyo Image technology

Hiroe
Koyanagi

Innovation Promotion Division, Research Promotion
Headquarters, Fujita Health University

Toyoake, Aichi

Continence care

Chiaki
Sakakibara

Home-visit nursing agency Yaya's House

Komatsu,
Ishikawa

Continence care,Home care nursing

Mihoko Seki * Nursing Department, JCHO Tokyo Yamate Medical
CenterShinjuku, Tokyo Continence care

MomokoTsuda *

Hokkaido Cancer Society

Sapporo,Hokkaido

Gastroenterology

MasaruMatsumoto

Graduate School of Adult Nursing, Ishikawa Prefectural
University of Nursing

Kahoku,Ishikawa

Imaging nursing

NoboruMisawa*Department of Gastroenterology and Hepatology,
Yokohama,
Graduate School of Medicine, Yohokama City University Kanagawa*: External cooperative members, JCHO: Japan Community Health Care Organization―5―

Gastroenterology3) Systematic review teamName

Affiliation

Location

Clinical Question

Aya Kitamura* Graduate School of Medicine, The University of Tokyo Bunkyo, Tokyo

CQ 2

Ayano Nakai

School of Health Sciences, Fujita Health University

Toyoake, Aichi

CQ 3,4,7

Ayumi
AmemiyaSchool of Nursing, Chiba University

Chiba City, Chiba

CQ 2

Beniko Itokawa Japanese Red Cross Akita College of Nursing

Akita City, Akita

CQ 4,6

Chikoto Suzuki Department of Nursing, Saiseikai Yokohamashi Tobu
Hospital

Yokohama,
Kanagawa

CQ 1,4,5

FumikoIshimitsu

Nagoya, Aichi

CQ 3,4,7

Masashi Katogi School of Nursing, Kanagawa University of Human
Service

Yokosuka,
Kanagawa

CQ 2,8Mayumi
HamadaThe Jikei University School of Nursing

Chofu, Tokyo

CQ 1,4,5

MikikoShimizu

School of Health Sciences, Fujita Health University

Toyoaki, Aichi

CQ 3,4,7

Miku Aoki

School of Medical Sciences, University of Fukui

Yoshida, Fukui

Misako Dai*

Graduate School of Adult Nursing, Ishikawa Prefectural Kahoku, Ishikawa
University of Nursing

CQ 3,4,7

Nozomi
SonodaSchool of Nursing, Takarazuka University

Osaka City, Osaka

CQ 4,8Rumi Tanaka

School of Nursing, Kitasato University

Sagamihara,
Kanagawa

CQ 1,4,5

School of Nursing & Health, Aichi Prefectural
University

CQ 4,8

Taiki Teshima Faculty of Nursing, Kansai Medical University

Hirakata, Osaka

CQ4, 8

Tamae Urai

Faculty of Nursing, Toyama Prefectural University

Toyama City,
ToyamaCQ 4,6

Tamami Mori

JCHO Tokyo Shinjuku Medical Center AffiliatedNursing School

Shinjuku, TokyoCQ 2, 4

Tomohiro
Ishinuki

School of Nursing, Sapporo Medical University

Sapporo, Hokkaido CQ 4,6

ToshiakiTakahashi*

Graduate School of Medicine, The University of Tokyo Bunkyo, Tokyo

CQ 4,6

Yuka Miura*

Research Center for Implementation Nursing Science
Initiative, Fujita Health University

CQ 4,8

Yuko Mugita*

Graduate School of Medicine, The University of Tokyo Bunkyo, Tokyo*: Team leader, JCHO: Japan Community Health Care Organization―6―

Toyoake, Aichi

CQ 1,4,5

4) Panel members
Name

Affiliation

LocationRole

Junko Sugama

Research Center for Implementation Nursing Science
Initiative, Fujita Health University

Toyoake, Aichi

Nursing technology development

Nao Tamai

Department of Nursing, Graduate School of Medicine,
Yokohama City University

Yokohama,
Kanagawa

Imaging nursing

KeikoIshihama*

Nursing Department, JCHO Hoshigaoka Medical
CenterHirakata, Osaka

Specialist in spinal cord injury andstroke, Rehabilitation nursing,Continence care

Erika Ota

Global Health Nursing, St. Luke's International
University

Chuo, Tokyo

Expert in creating clinical practiceguidelines

Miho Okabe*

Wound and skin home care station

Maebashi,
Gunma

Home care nursing,Continence care

Atsuo
Kawamoto*

Department of Radiology, Tokyo Medical University
Hospital

Shinjuku, Tokyo Imaging technology

Yoshifumi
Kido

Faculty of Nursing, School of Medicine, Hamamatsu
University

Hamamatsu,
Shizuoka

Psychiatric nursing

TakaomiKessoku*

Department of Palliative Medicine, The International
University of Health and Welfare Narita Hospital

Narita, Chiba

Gastroenterology,
Palliative medicine

Hiroe
Koyanagi

Research Center for Implementation Nursing Science
Initiative, Fujita Health University

Toyoake, Aichi

Continence care

Chiaki
Sakakibara

Home-visit nursing agency Yaya's House

Komatsu,
Ishikawa

Continence care,Home care nursing

Mihoko Seki*

Nursing Department, JCHO Tokyo Yamate Medical
CenterShinjuku, Tokyo Continence care

MomokoTsuda*

Hokkaido Cancer Society

Sapporo,Hokkaido

Gastroenterology

MasaruMatsumoto

Graduate School of Adult Nursing, Ishikawa Prefectural
University of Nursing

Kahoku,Ishikawa

Imaging nursing

NoboruMisawa*Department of Gastroenterology and Hepatology,
Yokohama,
Graduate School of Medicine, Yohokama City University Kanagawa*: External cooperative members, JCHO: Japan Community Health Care Organization

5) Cooperative member
Name

Affiliation

Kuniko Sato

Center for Academic Resources, St. Luke's International Chuo, Tokyo
University

Location

6) Secretariat
Name

Affiliation

Location

MasaruMatsumoto

Graduate School of Adult Nursing, Ishikawa Prefectural
University of Nursing

Kahoku,Ishikawa―7―

Gastroenterology7) External evaluation committee
Name

Affiliation

Location

Recommended Society

Eikichi Ihara

Department of Medicine and Bioregulatory
Science, Graduate School of Medical Sciences,
Kyushu University

Fukuoka City,
Fukuoka

The Japanese Gastroenterological
Association

Hiroyuki
ImaedaDepartment of Gastrointestinal Medicine, Saitama Iruma, Saitama
Medical University Hospital

The Japanese Society of
Gastroenterology

MichioMaruyama

Tanashi hospital

Nishitokyo,
Tokyo

Japanese Association for Home Care
Medicine

TakashiKawazoe

Carepro, Inc

Nakano, TokyoJapan Academy of Nursing for Home
Care

Takeya Yasushi Graduate School of Medicine, Osaka University

Suita, Osaka

The Japan Geriatrics Society

Toshiki
MimuraDepartment of Surgery, Division of
Gastroenterological, General and Transplant
Surgery, Jichi Medical University

Shimono,Tochigi

Japanese Society of Stoma andContinence Rehabilitation

Toshiko
Kaitani

Department of Gerontological Nursing, Graduate
School of Nursing, Sapporo City University

Sapporo,Hokkaido

Japanese Society of Wound, Ostomy &Continence Management

Yu Maruyama

Department of Nursing, Saitama Prefectual
University

Koshigaya,
Saitama

Japan Academy of GerontologicalNursing

8. Conﬂicts of interest (COI)
Economic COI and academic COI related to the development of this guideline were declared.
Method of investigation of potential COI: COI declarations were made according to the guideline of the
JANS. The table at the end of this report shows the status of COI for each participant for the three years immediately preceding the development of the guideline.
Description of economic COI: The following items were requested to be declared. Directorships and advisory
positions (1 million JPY or more), shareholdings (profits of 1 million JPY or more, 5% or more of all shares),patent royalties (1 million JPY or more), lecture fees (500,000 JPY or more), manuscript fees (1 million JPY or
more), research funds from companies and organizations (2 million JPY or more), scholarship donations (incentive donations), endowed courses (affiliation), and other rewards (more than 100,000 JPY).
Description of Academic COI: Experts in multiple fields and professions were invited to participate in thedevelopment of this guideline as members of the guideline development group or systematic review team, andefforts were made to eliminate the influence of individual expertise, the professional societies, academic development, and competition among organizations. All members were required to report any previous involvement in
the development of this guideline related to this subject or other similar guidelines.
Before initiating the development of this guideline, the members of the each committee were asked to submit
a COI declaration form to rule out any potential conflicts of interest that may affect the preparation of thisguideline. However, members who were authors of any published studies that were subject to the systematic
review were not assigned to the systematic review team. The first author was excluded from the panel meeting
when determining recommendations for clinical questions (CQs). In addition, we requested the submission of
conflict of interest reports in different years and verified any changes.

―8―9. Guideline development process1) Development policy
Chronic constipation may occur in hospital in-patients, nursing home residents, and in the home care setting.
The symptoms of difficulty in defecation experienced by patients with chronic constipation are straining, a feeling of residual stools, frequent stools, and a feeling of blockage at the perineum. In patients with chronic constipation, excessive straining to expel hard stools can cause a sudden rise in blood pressure, which may trigger
potentially life-threatening cardiovascular events. In addition, abdominal pain and bloating cause a decrease infood intake, affecting the nutritional status of the patient. Of note, in adults who are not always able to communicate their discomfort or need for defecation, chronic constipation may cause complications such as bowel
obstruction, rectal ulcer, and perforation of the gastrointestinal tract 1). On the other hand, excessive use of laxatives to treat constipation may lead to watery stool, which is not a healthy bowel movement, because it typicallydoes not lead to a feeling of well-being after defecation.
Nurses are required to support patients with chronic constipation in their daily lives to restore and maintainnormal bowel movements. Appropriate assessment is necessary for the treatment and care of constipation. The
conventional assessment methods include interview of the patient/caregivers and physical assessment. However,
it is difficult to obtain accurate information from adults who are not always able to communicate their discomfort and needs regarding bowel movements. In recent years, there has been an increased impetus for research andtraining programs regarding the use of point-of-care ultrasound imaging by nurses for the assessment of rectal
bowel movements. Therefore, there is a need to develop standardized guideline for ultrasound-based techniques
for the assessment of constipation that can be used in any setting, such as hospitals, nursing homes, and home,
and that can guide the selection of care in cooperation with physicians and other professionals.
Given this background, this guideline was developed in accordance with the “Minds Manual for Guideline
Development 2020 ver. 3.0"2) to facilitate decision-making regarding care selection based on research evidence
and multifaceted factors such as the balance of benefits and harms and the patient's value system. The CQs arethose that are encountered in actual situations of care selection for constipation, those that are difficult to decide,and those that are expected to improve clinical outcomes. Recommendations were made by panel members fromvarious decision-making positions. Due care was taken to ensure neutrality and transparency throughout theguideline development process.
A systematic literature search to address the CQs was conducted in both English and Japanese journals, andrecommendations were made after including a wide range of overseas evidence. When utilizing clinical guidelines published overseas, due cognizance was taken of the differences in medical systems between Japan andother countries.

2) Development process (Figure 2)
This guideline was developed in compliance with the Minds Manual for Guideline Development 2020 ver.
3.0 which adopts the internationally accepted GRADE framework (Grading of Recommendations Assessment,
Development, and Evaluation) for the classification of the strength of evidence.
(1) Organizational structure for creation
After the JANS clarified the purpose of creating this guideline, a guideline development steering committee―9―Clariﬁcation of the purpose of guideline development

Structure of the development organization
・Formation of Supervisory Committee
・Formation of Clinical Practice Guideline Development Group・Establishment of secretariat
・Formation of Systematic Review Team・Determination of cooperative members
Creation of scope・Determination of the overall scope creation policy
・Organize the basic characteristics of disease topics
・Determination of clinical questions
・Determination of systematic review-related matters
・Determination of scope
Systematic review
・Collection of evidence (determination of search formula, literature search)・Screening (primary screening, secondary screening)・Individual evaluation of evidence・Overall evaluation of the evidence
・Qualitative systematic review
・Meta-analysis
・Creation of report of systematic review
Development of recommendation
・Decision of panel members
・Determination of speciﬁc methods for making recommendations
・Drafting of recommendation text
・Determination of strength of recommendations, creation of recommendations
・Writing of commentary
・Writing of summaries for the general public
Finalization
・Discussion and decision of what to do after the release of the guidelines
・Preparation of a report on the preparation process・Determination of the draft guidelines
・Conduction of external evaluation
・Solicitation of public comments
・Determination of the ﬁnal draft of the guidelines
Publication

Post-publication eﬀorts
・Implementation
・Eﬃcacy evaluation
・Revisions

Figure 2: Guideline development process― 10 ―

was formed to initiate the process for the creation of clinical practice guideline. In accordance with the Minds
Manual for Guideline Development 2020 ver. 3.0 2), a guideline development group was formed in October
2021, a secretariat was set up, a systematic review team was formed, and a clinical practice guideline development organization was formed by deciding on cooperating committee members.
(2) Scoping
After the guideline development steering committee decided on the overall scoping policy, the guideline development group outlined the basic characteristics of the symptom topic (constipation) and selected the candidate CQs.
The selected candidate CQs were narrowed down to eight CQs under the supervision of the guideline development
steering committee (see Appendix). The guideline development group listed the clinically important outcomes foreach important clinical issue. Each member then scored the outcomes on a 9-point scale (from 1 to 9), and theaverage of the scores was calculated. For each narrowed-down CQ, items related to the systematic review were
determined. The items related to the systematic review included evidence search methods (evidence type, database,search method, and search period), criteria for selecting and excluding references, and methods for evaluating evidence and integrating results. After these steps, the scope was determined. Following the basic characteristics ofconstipation, especially functional constipation, and the algorithm for constipation assessment and care selection,
three main items were determined as the specific contents of the scope (items related to the contents covered byclinical guidelines, items related to systematic reviews, and items related to the process from making recommendations to finalization and publication). The first item, the content covered by the guideline, includes the title, purpose, scope, target patients, target audience, relationship with existing guidelines, important clinical issues, thescope of the clinical guideline, and a list of CQs. The second item, systematic review, includes the review schedule,
evidence search, literature selection criteria, inclusion/exclusion criteria, evidence evaluation, and methods for integrating the results. The third item, from recommendation development to finalization and publication, includes
the basic policy for recommendation development, finalization, specific methods of external evaluation, and publication schedule.
(3) Systematic review
A systematic review team member was appointed and a systematic review of each CQ was requested beginning in February 2022. During evidence collection, scoping-based evidence searches were conducted with theassistance of the university library librarian who had the necessary expertise and skills for the literature searchstrategy for systematic reviews. After the primary and secondary screening, the evidence was individually evaluated by performing a qualitative systematic review, and these were combined for a general evaluation of the evidence. The list of articles that were the subject of the qualitative systematic review was shared with the guideline
development committee members and the guideline development steering committee specializing in defecation
management to confirm that the list contained references that should be included. Based on the results, a systematic review report was prepared. Qualitative integration was used as the basis of the systematic review, in
accordance with the Minds Manual for Guideline Development 2020 ver. 3.0 2), but quantitative integration(meta-analysis) was used for some CQs because there were several studies with similar methods of evaluation.
The systematic review was completed in October 2022.
①Search for evidence
ⅰ．Evidence Type
Original Articles: Randomized controlled trials, Non-randomized controlled trials, Observational studies, Casestudies― 11 ―

Review Articles: Systematic Review
Existing guidelines: the "Evidence-based clinical practice guidelines for chronic constipation 2017 "3) (Researchsociety for the diagnosis and treatment of chronic constipation/ affiliated to the Japanese society of gastroenterology) was referred to for scoping and setting the CQs. However, for the systematic review, we did not use the resultsof this existing guideline as they were but conducted an all-new systematic review.
ⅱ．Databases
PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web (Japanese)ⅲ．Search Methods
The Patient, Intervention, Control, Outcome format was used to search for interventions. P and I were usedas the basis, and C and O were not specified.
ⅳ．Reference Period for Literature Search
All databases were searched until November 3, 2020.
②Criteria for selection and exclusion of references
Owing to the lack of any existing clinical guideline or systematic review article corresponding to the CQs in
this guideline that were prepared in accordance with the Minds Manual for Guideline Development 2020 ver.
3.0 2), a new systematic review was conducted for all of the CQs. For CQs on care selection interventions, priority was accorded to randomized controlled trials that met the inclusion criteria for the systematic review, butobservational studies and case studies were also included if there were no relevant randomized controlled trials.
For CQs on the sensitivity and specificity of assessments for care selection, observational studies that qualified
the selection criteria were included.
③Evaluation of evidence and integration of results
The methods for evaluation of the aggregate evidence and the method for expressing the strength of the aggregate evidence were in accordance with the “Minds Manual for Guideline Development for 2020 Ver. 3.0." 2)
Although qualitative integration was the basic method, quantitative integration (meta-analysis) was conducted
for CQ 4 because several studies had used similar evaluation methods.
(4) Creation of recommendations
The basic policy for making recommendations was based on the “Minds Manual for Guideline Development
2020 ver. 3.0."2) Considering that constipation requires care in a variety of clinical nursing settings, the panel
members were nurses certified in Wound, Ostomy, and Continence Nursing or nurses who provide excretorycare in any medical facility or at home, whether inpatient or outpatient. In addition, the panel members werecomposed of opinion leaders in their field, including a nurse certified in Wound, Ostomy, and Continence
Nursing providing recovery care for spinal cord injury and stroke patients,a researcher specializing in psychiatric nursing, gastroenterology physicians, a palliative medicine physician,and a radiology technician. A panel meeting was held in February 2023 to determine the recommendations foreach CQ. The panel members discussed the draft recommendations prepared by the guideline developmentgroup in accordance with the modified Delphi method, and the panel members agreed on the recommendations. The panel members who were the first authors of the articles adopted as evidence did not participate in
the determination of the recommendations for the CQs in question. However, the co-authors participated in thedecision on the recommendation of the CQ in a restrained and self-reflective manner, taking COI into account,as required by the proceedings of the panel meeting.
The recommendation panel made its decision based on the certainty of the evidence for all outcomes for CQ― 12 ―

(Table 1), the balance of benefits and harms, and a comprehensive consideration of the patient and clinical situation, including the values, intentions, burden, medical costs, and resources of the caregivers. The strength of
the recommendation is indicated by the certainty (strength) of the evidence, with 1 indicating “strongly recommended" and 2 indicating “weakly recommended." When a clear recommendation could not be made, it was
indicated as “None." In the description of recommendations, “Suggested" indicates a weak recommendation.
For assessment techniques for which there is no clear evidence, but which are considered important, the recommended level was determined as “recommendation by consensus of experts," reflecting the consensus among
the panel members based on the balance of benefits and harms, the values and intentions of the patient, burden,
medical costs and resources, and actual clinical experience.

Table 1: Certainty (strength) of evidence on overall outcomes for recommendation decisions
A (Strong)

Strong confidence in the appropriateness of the effect estimate to support recommendations

B (Moderate)

Moderate confidence in the appropriateness of the effect estimate to support recommendations

C (Weak)

Limited confidence in the appropriateness of the effect estimate to support recommendations

D (Very weak)

Little confidence in the appropriateness of the effect estimate to support recommendations(Adapted from the Minds Manual for Guideline Development 2020 ver. 3.0., p. 117)

(5) Finalization
After completion of the draft in February 2023, it was reviewed by the guideline development steering committee and revised in March 2023. External evaluation and public comments were collected from March to
April 2023. The guideline development group examined the results of the external evaluation and public comments and made revisions reflecting the results. In May 2023, the Nursing Care Development and Standardization Committee finalized and published the draft.

― 13 ―

10. Clinical question and summary of recommendation
1) Assessments covered by the guidelines
Assessments covered in this guideline include medical interview, defecation diary, physical examination techniques, digital rectal examination, and ultrasound imaging. Please refer to Part 1 for the specific details of each ofthese assessments.

2) List of CQs and recommendations

CQ 1
Is a systematic assessment using defecation diaries and interviews useful in the evaluation of constipation in adult patients who are not always able to communicate their discomfort and need for defecation?
Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, a systematic assessment using a defecation diary, which isnoninvasive, and a medical interview is recommended.
Strength of recommendation▶Recommendation by the expert panel[Note] Although there is insufficient evidence to recommend a systematic assessment using defecation diaries and interviews, the panel committee decided tomake a recommendation based on expert opinion. Since patients themselves are
not always able to communicate, care should be taken to seek information fromfamily members and caregivers who understand the patient's daily life.

CQ 2
Is systematic assessment using physical examination techniques (inspection, auscultation, palpation, and percussion) useful in the evaluation of constipation in adultpatients who are not always able to communicate their discomfort or need for bowel
movements?
Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is recommended that a systematic assessment be performed using noninvasive physical examination techniques (inspection, auscultation, palpation, and percussion).
Strength of recommendation▶Recommendation by the expert panel[Note] Although there is insufficient evidence to recommend an assessment using
physical examination techniques (inspection, auscultation, palpation, and percus-― 14 ―

sion), the panel committee decided to make a recommendation based on expert
opinion.

CQ 3
Is assessment by digital rectal examination useful in the evaluation of rectal fecal
impaction during constipation in adult patients who are not always able to communicate
their discomfort or need for defecation?
Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is strongly recommended that a digital rectal assessment
be performed to evaluate rectal fecal retention during constipation.
GRADE 1D (Strength of recommendation：strong，Certainty of evidence (strength)：very weak)[Note] Although there is insufficient evidence to recommend assessment by digital
rectal examination, we decided to recommend it based on expert opinion
because digital rectal examination can assess the presence or absence of stool
in the rectum and is a reference standard for other CQs. The target patients ofthis guideline may not always be able to communicate their discomfort or needregarding defecation. When performing digital rectal examination, due consideration should be given to the stress induced by the procedure due to feelings ofshame, pain, and discomfort.

CQ 4
Is the assessment of rectal stool retention by ultrasound imaging useful in the evaluation of constipation in adult patients who are not always able to communicate their discomfort or need for defecation?
Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is strongly recommended that rectal fecal impaction beassessed by ultrasound imaging to determine rectal fecal impaction.
GRADE 1C (Strength of recommendation：strong，Certainty of evidence (strength)：weak)[Note] It is assumed that the patient understands how constipation can beassessed by means of a medical interview, defecation diary, and physical examination techniques. Ultrasound imaging for the detection of rectal fecal impaction
should be performed by a nurse who has received specific training in this technique. In addition, the ultrasound imaging should be compatible with a convex― 15 ―

probe as a prerequisite for adequate rectal observation. The probe should havea frequency in the range of 3.5 to 5 MHz and a resolution level that can delineate the bladder, uterus/vagina, prostate, and rectum.

CQ 5
Is defecation care based on systematic assessment using defecation diaries and interviews useful for improving patient outcomes in adult patients who are not always able
to communicate their discomfort and need regarding defecation?
Recommendation
We propose the implementation of defecation care based on systematic assessment using defecation diaries and interviews with adult patients who are notalways able to communicate their discomfort or need regarding defecation.
GRADE 2D (Strength of recommendation：week，
Certainty of evidence (strength)：very weak)[Note] Since patients themselves are not always able to communicate, care should
be taken to seek information from family members and caregivers who understand the patient's daily life.

CQ 6
Is defecation care based on systematic assessment using physical examination techniques (inspection, auscultation, palpation, and percussion) useful for improving
patient outcomes in adult patients who are not always able to communicate their discomfort or need for defecation?
Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is recommended that defecation care be based on systematic assessment using abdominal physical examination techniques (inspection,
auscultation, palpation, and percussion).
Strength of recommendation▶Recommendation by the expert panel[Note] Although there is insufficient evidence to recommend defecation carebased on a systematic system assessment using physical examination techniques(inspection, auscultation, palpation, and percussion), the panel committee madethis recommendation based on expert opinion.

― 16 ―

CQ 7
Is defecation care based on the assessment by digital rectal examination useful for
improving patient outcomes in adult patients who are not always able to communicate
their discomfort or need for defecation?
Recommendation
Defecation care based on digital rectal examination is strongly recommended in
adult patients who are not always able to communicate their discomfort or needfor defecation.
GRADE 1D (Strength of recommendation：strong，Certainty of evidence (strength)：very weak)[Note] Although there is insufficient evidence to recommend assessment by digital
rectal examination, we decided to recommend it based on expert opinion
because it can enable the assessment of the presence or absence of stool in therectum and is a reference standard for other CQs. The target patients of thisguideline may not always be able to communicate their discomfort need regarding defecation. When performing digital rectal examination, due consideration
should be given to the stress induced by digital rectal examination due to feelings of shame, pain, and discomfort.

CQ 8
Is defecation care based on observation of rectal stool retention by ultrasound imaging
useful for improving patient outcomes in adult patients who are not always able to communicate their discomfort and need for defecation?
Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is strongly recommended to implement defecation carebased on ultrasound imaging to detect rectal stool retention.
GRADE 1C (Strength of recommendation：strong，Certainty of evidence (strength)：weak)[Note] Ultrasound imaging should be performed by nurses trained in the observation of rectal fecal impaction. The ultrasound imaging should be compatible witha convex probe as a prerequisite for adequate rectal observation. The probeshould have a frequency in the range of 3.5 to 5 MHz and a resolution level thatcan delineate the bladder, uterus/vagina, prostate, and rectum.

― 17 ―

11. Glossary1) Important term
Rome Ⅳ
ROME IV criteria describe the disease concept and diagnostic criteria for functional gastrointestinal disorders.
The Rome I criteria were developed in 1992 and have been revised since then, with the Rome VI criteria published in 2016 4). The criteria are relevant to functional bowel disorders. The content of this guideline falls within the purview of functional bowel disorders, including disease concepts and diagnostic criteria for irritablebowel syndrome, functional constipation, functional diarrhea, functional bloating, nonspecific functional bowel
disorders, and opioid-induced constipation.

2) List of abbreviations (Table 2)
The abbreviations used in this guideline are listed below.
Table 2: Abbreviation list
Abbreviation

Full spellAS

Acoustic shadow

BSFS

Bristol stool form scale

CAS

Constipation assessment scale

CDSR

The Cochrane Database of Systematic Reviews

CENTRAL

The Cochrane Central Register of Controlled Trials

CSS

Constipation scoring system

Minds

Medical Information Distribution Service

JPAC-QOL

Japanese version of the patient assessment of constipation quality of life

PAC-SYM

Patient assessment of constipation–symptom questionnaire

12. Scope of coverage and focus of the guideline
This guideline covers the assessment of colonic fecal retention performed as part of nursing care for constipation. Specimens, abdominal radiography, enteral radiography, endoscopy, and specialized functional tests for the
diagnosis of constipation performed by professionals other than nurses are beyond the scope of this guideline.
Ultrasound imaging for detecting rectal stool retention should only be performed at facilities or hospitals witha compatible ultrasound device and should be performed by nurses who are adequately trained in the observation technique.

― 18 ―

13. Relationship to existing guidelines
There are no guidelines for the assessment of colonic retention during constipation in adults in Japan or overseas, which are designed to be used by nurses to select care.
In Japan, “Evidence-based clinical practice guidelines for chronic constipation 2017"3) (edited by Researchsociety for the diagnosis and treatment of chronic constipation/ Affiliated to the Japanese society of gastroenterology) and “Evidence-based clinical practice guidelines for chronic constipation 2023"5) (edited by the Japanese gastroenterological association" have been published as clinical guidelines for physicians on chronic constipation. Clinical guidelines mainly cover diagnostic evaluation tests such as medical history, physical examination,
routine examination, and specialized functional tests. However, these do not cover point-of-care ultrasound performed by nurses. The Japanese Society of Wound, Ostomy, and Continence Management, The Society for
Nursing Science and Engineering, and the members of the Consensus Meeting of the 22nd Annual Meeting of
the Japanese Society of Neurogastroenterology published a book titled the “Best Practices for Observation of
Rectal Stool Retention Using Ultrasonography "6) in 2021. The book focuses on observation using ultrasoundimaging and does not discuss other interviewing and physical examination techniques performed by nurses.
Overseas, the World Gastroenterology Organization Global Guideline titled “Constipation: a global perspective"7) was published in 2010. The guideline discusses various examinations for diagnostic evaluation of constipation in adults. However, it does not cover ultrasound imaging performed by nurses. This guideline was developed with reference to these existing publications to promote the assessment of colonic fecal retention during
nursing care for constipation.

14. Results of external evaluation and reﬂection in the guideline
The draft of this guideline was externally evaluated by representative academic organizations specializing in
gastroenterology, geriatrics, gerontology, gerontological nursing, continence rehabilitation, continence care,home health care, and home health care nursing, as well as by experts in the development of clinical guidelines,
prior to its release to the public.
These representative academic organizations provided written evaluations and comments from the perspectiveof the clinical significance and practical application of the draft as a whole.
In addition to the word correction, the following two issues were pointed out for consideration.

●Question
Does the target population for this guideline include those with an elevated rectal sensory threshold (rectal
sensory insensitivity)?
【Answer】
It was decided to add the following to the list of target populations: (1) those with rectal sensory insensitivityand (2) those with defecation suppression.

― 19 ―

●Opinion
Since the digital rectal examination covered in CQ3 and CQ6 can evaluate the presence or absence of stool in
the rectum and is used as a reference standard for other CQs, it is recommended that the level of recommendation be changed from “recommendation by expert panel" to GRADE 1D (Strength of recommendation: Strong;
Certainty (strength) of evidence: Very weak).
【Answer】
This opinion of external committee members was reviewed by the guideline development steering committee
and the recommended change was approved for incorporation in the guideline.

15. Minds preliminary evaluation and reﬂection in the guideline
A pre-publication evaluation was received on May 2 from four members of the Clinical Guideline Evaluation
Committee (date of approval of the evaluation results: May 15, 2023). The general comments of the responsible
subcommittees were as follows. The AGREE II evaluation table is shown in Table 3, and as much as possible,
the comments from Minds are reflected in this guideline.

●Advanced reviews
In the AGREE II evaluation, the description of the subject and purpose areas was highly rated and is seen as amodel for other clinical guidelines. The purpose of the clinical guideline is described in detail. The method ofmaking recommendations is also described in detail, and the disclosure of the materials used from the literaturesearch to the determination of recommendations is highly evaluated. The content of this guideline is describedin two parts, the general and CQ parts, which is seen as useful for users of this guideline. For further improvement of the clinical guideline, the process of making recommendations should be more clearly described indetail. In particular, it would be helpful to present the results of the modified Delphi method. As for the search
formula, there is a statement that it is included as an Appendix (e.g., p. 52), and it would be more transparent todisclose it as supplementary material to enhance the transparency of the preparation process. Regarding external
evaluations, the results of the evaluations should be described, and the methodology used to integrate these in
the process of developing the clinical guideline should be described in detail.
Please consider responding to the items pointed out in the public comments and the revisions made, as statedon the website of the Society (p. 18). Regarding revisions to the clinical guideline, it would be helpful to provide
more specific information on the revision procedures (e.g., the system for reviewing revisions). Another issue isto consider and describe factors that promote or hinder the use of the clinical guideline, tools to support theirapplication, cost information, and standards and methods for monitoring and auditing to evaluate the dissemination and use of the clinical guideline. Efforts made to reflect the values and wishes of patients and families in
the process of developing the clinical guideline is expected. It would be desirable to describe the methods andresults of the efforts, and how they were reflected in the clinical guideline in detail. In addition, since the overall
impression is that the document is difficult to read, it is recommended to devise a layout that makes it easier tofind recommendations, such as by framing recommendations with a frame or coloring them.

― 20 ―

Table 3: Summary of the results of AGREEII's external evaluation of the pre-publication draft
Domain1

2

3

Scope and Purpose

Stakeholder Involvement

Rigour of Development1

The overall objective(s) of the guideline is (are) specifically described.

6.5

2

The health question(s) covered by the guideline is (are) specifically described.

5.75

3

The population (patients, public, etc.) to whom the guideline is meant to applyis specifically described.

6.25

4

The guideline development group includes individuals from all the relevant
professional groups.

6.75
2.75

5

The views and preferences of the target population (patients, public, etc.) havebeen sought.

6

The target users of the guideline are clearly defined.

5.75

7

Systematic methods were used to search for evidence.

5.75

8

The criteria for selecting the evidence are clearly described.

5.5

9The strengths and limitations of the body of evidence are clearly described.

6.5

10 The methods for formulating the recommendations are clearly described.

4.75

The health benefits, side effects, and risks have been considered in formulating11
the recommendations.

5.75

There is an explicit link between the recommendations and the supporting
evidence.

6

12

4

5

Clarity of Presentation

Applicability

13 The guideline has been externally reviewed by experts prior to its publication.

4.25

14 A procedure for updating the guideline is provided.

4.75

15 The recommendations are specific and unambiguous.

5.25

The different options for management of the condition or health issue are
16
clearly presented.

3.75

17 Key recommendations are easily identifiable.

3.25

18 The guideline describes facilitators and barriers to its application.

4.5

The guideline provides advice and/or tools on how the recommendations can
19
be put into practice.

4

The potential resource implications of applying the recommendations havebeen considered.

4.25

20

21 The guideline presents monitoring and/ or auditing criteria.

6

5

22

The views of the funding body have not influenced the content of theguideline.

5.25

23

Competing interests of guideline development group members have beenrecorded and addressed.

6.25

Editorial Independence●Comment 1
It would be good to have a structure to survey and reflect the values and wishes of the target population.
【Answer】
The target population for this guideline is "adult patients who are not always able to communicate their discomfort or need regarding defecation." This makes it difficult to find evidence regarding values and wishes. Thisis an important perspective for determining recommendations and should be an issue for the Nursing Care
Development and Standardization Committee.

●Comment 2
The addition of an evidence search formula would make the creation process more transparent.
【Answer】
Evidence search formulas have been added to the Appendix.

― 21 ―

●Comment 3
It would be good to have a description of the results of the modified Delphi method.
【Answer】
In this guideline, the following notation was made. “The decision was made by consensus of the panel members after discussion at a panel meeting on a draft recommendation prepared by the guideline developmentgroup in accordance with the modified Delphi method."●Comment 4
Please consider describing the content of the public comments and external evaluation and how you responded to them.
【Answer】
Response to comments received from public comments and external evaluation is included in the finalization
section.

●Comment 5
For CQs and recommendations, we recommend incorporating double quotation marks, coloring, or otherdevices to make them easier to find.
【Answer】
The background of the CQ is now red to make it easier to find. Also, the recommended text is now in bold.

●Comment 6
There is a section listing key clinical issues, CQs, and recommended statements, but it would be easier to read
if they were presented in a table.
【Answer】
See response to comment 7.

●Comment 7
It would be more convenient if the list of important clinical issues, CQs, and recommendation statements
were listed at the beginning of the document, following the Table of Contents.
【Answer】
A list of CQs and recommended statements are included at the beginning following the Table of Contents.

●Comment 8
It was mentioned that COI are indicated in the Appendix at the end of the book, so it would be a good idea tomention them in the final version.
【Answer】
A list of COI has been added to the Appendix.

― 22 ―

16. Public comments and reﬂection in the guideline
Public comments were solicited after preparing the draft, in parallel with the external evaluation and prior to
its release to the public. The invitation for public comments was disseminated to the members of the JANS by email, and the draft was posted on the members' page of the JANS from March 23 to March 31, 2023. Comments were obtained in the form of open-ended responses.
Public comments were submitted by two persons. The comments and the responses are listed below. The
comments and responses were also posted on the JANS website.

●Opinion
I think it is very comprehensive. I think this nursing care guideline can be used in all aspects of nursing, but I
suspect that when reviewing the content on the web, some will find it difficult to use because of the large number of words and long sentences. In the future, it would be helpful if the structure could be made so that thecontent can be used while using a tablet device.
【Answer】
We plan to publish this guideline in print and upload a PDF of the print version on our website. We believethat the readability of the guideline is a major influencing factor for its dissemination. After publication, we
would like to work with the Public Relations Committee to consider the structure of the guideline to make iteasier to use in electronic media.

●Question
If there is a blunting of rectal sensation due to chronicity in relation to “awareness of rectal fecal impaction,"
it would be easier to understand if the perspective of assessment of sensory function regarding awareness of rectal
impaction could be clarified.
(e.g., “awareness of rectal retention" should be added to the subject's conditions, such as excluding cases of
constipation with rectal sensory blunting due to chronicity).
【Answer】
Thank you for your important comments regarding the target population for this guideline. We have decided
to add (1) those with rectal sensory insensitivity, and (2) those with defecation suppression, to the list of subjects.

17. Funds
Funding for the development of this guideline was provided by the JANS. No funding was received fromother private companies or organizations. Self-reported COI were collected from the committee members andexamined in accordance with the regulations of the JANS. It was confirmed that there were no COI issues. Conflicts of interest that should be disclosed are listed in the clinical guideline “Outline 8: COI."― 23 ―

18. Audit Standards
The relationship between the assessment and the care choices made, and the relationship between chronic
constipation (functional constipation), defecation management in the form desired by the patient, and other factors will be monitored every six months to one year.

19. Dissemination and implementation of the guideline
This guideline concisely summarizes the recommendations for the eight CQs, clearly indicating what is
important in an easy-to-understand manner. The interview and physical examination techniques which are useful for patients with suspected chronic constipation (functional constipation) and do not require special equipment are facilitating factors in the application of the clinical practice guidelines. On the other hand, digital rectal
examination and ultrasound examination for observation of rectal stools must be performed by adequately
trained persons. Therefore, the limited number of facilities that have the necessary equipment and trained personnel for these examinations are potential barriers. The training of personnel in these observation techniques is
an important issue for the future.
Both the Japanese and English versions of this guideline will be published in full on the websites of the JANS
and Minds. Further, the Japanese version will also be published as a book. This guideline also include a summary for the public. In addition, a systematic review will be published in the Japan Journal of Nursing Science.
Moreover, we aim to promote the use of this guideline by holding lectures at various academic meetings andother events.

20. Post-publication eﬀorts
1) Organizational structure after release
After the release of the clinical guideline, the guideline development steering committee and the guideline
development group will continue their activities to promote the introduction of this guideline, evaluate its effectiveness, and check for new research findings that may affect the recommendations in this guideline.

2) Efficacy evaluation and monitoring
To evaluate the effectiveness of this guideline, we plan to assess whether the introduction of the guideline has
improved patient outcomes in terms of stool characteristics, rectal retention, laxative use, and other outcomes.
These will be measured every year from the time of introduction of the clinical guideline.

3) Revision cycle
This guideline will be revised periodically according to new evidence and changes in the medical care system.
Revisions will be considered approximately every three to four years. Revisions may be considered earlier if new― 24 ―

physical examination techniques, screening tests, definitive diagnostic methods, or assessment criteria are proposed.

References
1)
2)
3)
4)
5)
6)

7)

Nakjima A ed.. Diagnosis of constipation every clinician should know, YODOSHA co.,LTD, Tokyo, 2022. (in Japansese)
Minds Manual Developing Committee ed. Minds Manual for Guideline Development 2020 ver. 3.0. Tokyo: Japan
Council for Quality Health Care, 2021. (in Japansese)
Constipation-study group, Organization of The Japanese Society of Gastroenterology ed.. Evidence-Based Clinical Practice Guidelines for Chronic Constipation 2017, Nankodo Co., Ltd., Tokyo, 2017. (in Japansese)
Lacy BE, Mearin F, Chang L, et al. Bowel disorders. Gastroenterology 2016; 150: 1393-1407.
The Japanese Gastroenterological Association (edit). Evidence-Based Clinical Practice Guidelines for Chronic Constipation 2023. Nankodo Co., Ltd., Tokyo, 2023. (in Japanese)
The Japanese Society of Wound, Ostomy & Continence Management, and The Society for Nursing Science and Engineering ed.. Best Practice for observation of rectal fecal impaction using ultrasonography, Shorinsha Inc., Tokyo, 2021.
(in Japansese)
Lindberg G, Hamid SS, Malfertheiner P, et al. World Gastroenterlogy Organisation global guideline: Constipation- a
global perspective. J Clin Gastroenterol 2011; 45: 483-487.

― 25 ―

Part 1.
Constipation

The purpose of this guideline is to guide the assessment of defecation, especially constipation, in adultpatients who may not always be able to communicate their discomfort or need for defecation. Adoption of theseguidelines can enable nurses to provide early and appropriate constipation care, prevent bowel obstruction andperforation, and help patients comfortably expel feces that should otherwise be expelled. These guidelines are
particularly relevant during the nursing care of patients with dementia, stroke, brain injury, spinal cord injury,
and Parkinson's disease. These guidelines may also apply to patients receiving opioid medications for palliativecare. Additionally, these can be used for patients with rectal hypersensitivity (e.g., due to aging), and for those
who have lost the urge to defecate due to continuous suppression of defecation.
Note that organic constipation caused by physical gut obstruction, due to lesions such as cancer, rectal, mass,or rectal prolapse, is not covered by these guidelines.

1. Clinical characteristics
1) Definition
The Evidence-based clinical practice guidelines for chronic constipation 2023 1), published in 2023, defines
constipation as a condition characterized by fecal impaction or hard stools, decreased frequency of defecation,
excessive irritation due to inability to defecate comfortably, a feeling of residual feces, blockage of the rectum
and anus, and difficulty in defecation due to retention of feces in the large intestine. Chronic constipation isdefined as "a condition that can interfere with the daily life or cause various physical disturbances due to chronic
persistent constipation" (Evidence-based clinical practice guidelines for chronic constipation 2023). Table 1 lists
the diagnostic criteria for chronic constipation.
Table 1: Diagnostic criteria for chronic constipation (based on Rome IV diagnostic criteria)
1. Diagnostic criteria for functional constipation (FC)The symptoms of FC must include two or more of the following:
Defecation core symptom- C1 (Stool form) Lumpy or hard stools (BSFS type 1 or 2) more than25% of defecations.
- C2 (Frequency of bowel movements) Fewer than three spontaneous bowel movements per week
Defecation peripheral symptom- P1 (Straining) Straining more than 25% of defecations.
- P2 (Sensation of incomplete evacuation) Sensation of incomplete evacuation more than one-fourth (25%) of defecations.
- P3 (Sensation of anorectal obstruction/blockage ensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations- P4 (Manual maneuver) Manual maneuvers to facilitate more than one-fourth (25%) of defecations.
2. Diagnostic criteria for chronicity
Symptoms must have been present for at least 6 months and have met the above criteria for the last 3 months. However, in “routine medicalcare," this is left to descrition of the physician examining the patient.
BSFS: Bristol stool form scale(Lacy BE, et al. Gastroenterology 2016; 150: 1393-1407)(The Japanese Gastroenterological Association (edit). Evidence-Based Clinical Practice Guidelines for Chronic Constipation 2023. Nankodo Co., Ltd.,Tokyo, 2023. (in Japanese))2) Classification
The classification of chronic constipation is shown in Table 2 2). Constipation is broadly classified into organic constipation with morphological changes and functional constipation without morphological changes,― 28 ―

Table 2: Classification and mechanism of constipation
Organic constipation
Stenotic constipation

Physical passage obstruction due to cancer or other causes

Non-stenotic constipation

Constipation due to organic fecal discharge disorders such as rectal mass orrectal prolapse.

Functional constipation
Constipation with decreasedstool frequency- Slow transit constipation: Delays the time for the stool to pass through thecolon- Normal transit constipation: Constipation type of hypersensitivity
hypersyndrome, etc.

Difficult to defecate constipation Impaired stool evacuation at the rectum and anus
Secondary (symptomatic) constipation is due to underlying diseases such as endocrine disorders, collagendiseases, neurological diseases, etc.
Drug-induced constipation is due to psychotropic drugs, anticholinergics, opioids, etc.
Idiopathic constipation has no identifiable cause(The Japanese Society of Wound, Ostomy, and Continence Management (edit). New Edition Excretory Care Guidebook.
Shorinsha Inc., Tokyo, 2023. (in Japanese))depending on the cause of constipation. Organic constipation is further classified into stenotic constipation
caused by colorectal cancer or intestinal inflammation and non-stenotic organic constipation (small
intestine/colon type and rectum/anal type) caused by lesions obstructing fecal discharge such as rectal mass orrectal prolapse. Functional constipation is classified into "decreased stool frequency type" and "difficult defecation type" based on the symptoms. Decreased stool frequency refers to the condition wherein the feces are
retained in the colon, while difficulty in defecation refers to the condition wherein the feces present in the rectum cannot be comfortably excreted. Note that there is a possibility of overlap between the decreased stool frequency type and the difficult defecation type. Other types of constipation include secondary (symptomatic),
drug-induced (including opioid-induced constipation), and idiopathic.

3) Pathophysiology of constipation
The pathophysiology of constipation is believed to involve a combination of three main factors: (1) inadequate dietary intake leading to insufficient amount of feces; (2) decreased gastrointestinal transport capacity; and(3) failure to excrete stool mass in the rectum due to abnormal rectoanal function, such as intentional inhibitionof bowel movements, decreased bowel movements, and failure to relax the anal sphincter muscle. Elderly
patients are prone to constipation because of the inability to apply adequate abdominal pressure due to decreased
strength of the abdominal muscles.
Changes in the living environment, such as underlying disease, oral medications, decreased physical activity,and decreased fluid intake, may also cause constipation.

4) Anatomy and functions of defecation
The organs involved in defecation include the small intestine, colon, rectum, and anus (Figure 1)3).
The final part of the rectum is called the ampulla, which narrows abruptly to form the anal canal (Figure 2)3).
The anal canal is a double-layered structure consisting of the internal anal sphincter, an involuntary muscle, andthe external anal sphincter, a voluntary muscle. The internal anal sphincter constantly tightens the anus with aconstant force. The external anal sphincter surrounds the internal anal sphincter and plays an important role inthe voluntary closure of the anal canal.

― 29 ―

Transvers colon

Splenic ﬂexure

Mesocolon transversum

Hepatic ﬂexure
Treitz ligament
Colic tenia

Jejunum
Mesentery

Ascending colon

Bauhin's valve(Ileocecal valve)
Cecum

Descending colon
Ileum
Ileocecal
regionMesocolon sigmoideum
Sigmoid colon

Appendix
Mesoappendix
Fixed directly to theAnusretroperitoneum
non-movable parts

Peritoneum
RectumFigure 1: Schematic illustration of the lower gastrointestinal tract(Anazawa S., et al (edit). Excretion Rehabilitation: Theoretical and Clinical. Nakayama Shoten Co., Ltd., Tokyo, 2009. (inJapanese))

Peritoneum

Levator ani①
Rectal ampulla

Anal canal

Musculus puborectalis
Deep

Dentateline②

Shallow

External anal sphincter

Subcutaneous

Anal verge

Internal anal sphincter① Area where the hindgut descends: No pain is felt
② Area where the ectoderm is depressed: Pain is felt

Figure 2: Anatomy and origin of the rectoanal region(Anazawa S., et al (edit). Excretion Rehabilitation: Theoretical and Clinical. Nakayama Shoten Co., Ltd., Tokyo, 2009. (in Japanese))― 30 ―

At rest

Musculus puborectalis
External anal sphincter

During defecation

Anorectal angle
Defecation

Anorectal angle

Internal anal sphincter

Figure 3: Schema at rest and during defecation(Lembo A, Camiller M. N Engl J Med 2003; 349 (14): 1360-1368)

Food that enters the mouth is digested in the stomach and the nutrients are digested and absorbed in thesmall intestine. Entry of the food into the stomach induces the gastrocolic reflex, causing peristalsis of the colon,
which results in the propulsion of the food from the small intestine to the large intestine. From the sigmoid
colon, the stool is transported to the rectoanal region, where it is temporarily retained before its expulsion (Figure 3)4).
The normal sequence of defecation is as follows. Entry of stool into the rectum stretches the rectal wall andthe internal anal sphincter, increasing rectal pressure. When the rectal pressure reaches approximately 40–50
mmHg, the brain senses the need for defecation via the pelvic nerve, leading to the relaxation of the internal anal
sphincter. Simultaneously, the external anal sphincter and the puborectal muscles contract strongly via the pubic
nerves to hold the stool. This is referred to as the rectoanal reflex. In conditions that are unsuitable for defecation, the external anal sphincter and puborectalis muscles contract, and the rectoanal angle is sharply angled toprevent the stool from leaking out (Figure 3, left, at rest).
When defecation is possible, deliberate application of abdominal pressure and simultaneous relaxation of theexternal anal sphincter and puborectal muscles causes the perineum to descend and the rectoanal angle tobecome obtunded, which straightens the rectum and facilitates defecation (Figure 3, right, during defecation).
At the end of defecation, the anus, which had been dilated by the passage of stool, contracts, and under normal conditions, there is no residual stool in the rectum after defecation (Figure 3, left, at rest).
Functional constipation occurs due to the impairment of the coordinated movement of pelvic floor muscles
or rectal sensation.

5) Diagnosis 1)
Chronic constipation, diagnosed based on symptoms, can be classified as primary or secondary, as describedabove. The underlying disease or condition is inferred from the interview and physical examination, and thenecessity of further investigations (blood tests, colonoscopy, abdominal X-ray, and enteroscopy) are individually― 31 ―

determined and performed to differentiate secondary constipation (drug-induced constipation, symptomaticconstipation, and stenosing organic constipation).
Although blood tests are useful in identifying secondary constipation, the need for further investigations
should be performed only after careful evaluation of the medical history and physical examination, which often
provide clues to the underlying condition. Fecal occult blood test is a screening test for colorectal cancer.
Colonoscopy is useful mainly for differential diagnosis of stenosing organic constipation associated with neoplastic and inflammatory diseases.
Abdominal radiography is useful for the early detection or exclusion of organic diseases such as intestinal
obstruction and colonic axis torsion by observing intestinal gas retention and bowel compression due to masses.
Similar to colonoscopy, enteral radiography is used in patients in whom stenosing organic constipation must be
ruled out.
CT and MRI are used to evaluate colonic fecal impaction, and recently, the usefulness of abdominal ultrasonography in the diagnosis and treatment of constipation has been reported 1, 5).
In addition, to evaluate the pathophysiology, especially in patients with intractable chronic constipation, specialized functional tests such as colon transit time test, defecography, balloon emptying test, rectoanal pressure
test, and rectal sensory test are performed. The colonic transit time test objectively evaluates the peristalsis of thelarge intestine and is useful for classifying constipation with decreased frequency into delayed colonic transit typeand normal colonic transit type. The radiopaque marker method is the most widespread worldwide; however,
SITZMARK®, which is used as the marker, has not been approved by the pharmaceutical affairs bodies or listedon the health care registry in Japan as of March 2023. The time from oral ingestion of the marker to its expulsion from the anus is evaluated. Defecography is a dynamic intrarectal radiographic examination in which pseudo feces are injected transanally into the rectum with a contrast medium to observe the dynamics of the rectum,
sigmoid colon, and pelvic floor musculature during the act of defecation. In the balloon voiding test, a waterfilled balloon is implanted in the rectum to evaluate the voiding ability in the sitting position. It evaluates thepresence or absence of functional fecal discharge disorders such as pelvic floor muscle dyskinesia. Rectal and analmanometry measures the internal pressure in the rectum and anal canal to evaluate the contractility of the anal
sphincter, changes in rectal pressure during effort, and the rectoanal reflexes. Rectal sensory testing evaluates thesensory capacity of the rectum and includes rectal balloon sensory testing and rectal mucosal stimulation threshold testing.

2. Epidemiological characteristics
In the National Survey of Living Conditions, constipation is included as one of the digestive system symptoms in response to the question "Do you have any symptoms of illness or injury in the past few days that makeyou feel sick (subjective symptoms)?" Based on the results of the 2019 National Survey of Living Conditions 6),
the prevalence of constipation (per 1000 population) disaggregated by gender and age group was prepared (Figure 4). From teens to 50s, the prevalence rate of constipation in women was higher than that in men. The
prevalence of constipation in patients aged ≥65 years (per 1,000 population) was 164 for men and 181 for
women.

― 32 ―

Rate of appellants (in thousands of population)

90
80
Men

70

Women

60
50
40
30
20
10
0

Under
9 years
old

10〜19

20〜29

30〜39

40〜49

50〜59

60〜69

70〜79

Over
80 yearsold

Figure 4: Percentage of constipation prevalence by age group and gender(Comprehensive survey of living conditions 06 Statistical Tables (2nd Revision 0629) (mhlw.go.jp). (in Japanese))

The prevalence of constipation in post-stroke patients was 48% (95% confidence interval [CI] 33–63%)7).
The prevalence rates differed by stroke type: ischemic stroke, 51% (95% CI 27–75); hemorrhagic stroke, 66%(95% CI 40–91). In terms of stage of disease, the prevalence was 45% (95% CI 36–54) in the acute phase and
48% (95% CI 23–73%) in the rehabilitation phase.
In a survey 8) of 202 inpatients in the convalescent group, 168 (83%) were prescribed laxatives, either daily orintermittently. Laxatives were prescribed to more than 70% of the patients regardless of their method of defecation, especially to diaper users (159 patients), 86% of whom were prescribed laxatives. Laxatives were prescribedto 87% (119/137) of patients with cerebrovascular disease.

3. Constipation assessment
1) Assessment and nursing care objectives and methods
The purpose of constipation assessment and defecation care in nursing is to assess and recommend defecationin adult patients who may not always be able to communicate their discomfort or need for defecation. The goal
is to provide early and appropriate constipation care to prevent complications such as bowel obstruction andbowel perforation, as well as to enable the patient to pass stools in sufficient volume and comfort.
In the defecation care system, the presence or absence of suspected constipation is determined, followed by acomprehensive assessment of abdominal and anal symptoms, the underlying cause, imaging studies, defecation
movements, and lifestyle. Based on the assessment results, a defecation care plan is developed and implemented.
The goal of these measures is to achieve as safe, comfortable, and independent defecation as possible (Figure 5).
Constipation assessment and defecation care are ideally performed by a multidisciplinary team comprising of― 33 ―

Suspicion of constipation

Observation and information gathering
Abdominal and anal symptoms

Pathophysiology of primary disease

Imaging tests, etc.
Defecation behavior

Lifestyle

Evaluation of constipation
Plan for defecation care
Provide defecation careSafe, comfortable, and independent defecation as possible

Figure 5: System of defecation carea physician, nurse, pharmacist, physical therapist, occupational therapist, dietitian, nursing staff, medical social
worker, and family members.

2) Algorithm for assessment-based nursing care
Figure 6 shows the flow chart of information collection and assessment, goal setting based on these assessments, and selection of care to be implemented, to realize safe and comfortable defecation. This algorithm wasdeveloped under the AMED (“Japan Agency for Medical Research and Development") Longevity Science
Research and Development Project “Construction of a Multidisciplinary Collaboration System to Support Eating, Swallowing, and Defecation for People Cared for at Home and in Nursing Homes by Introducing
Advanced Nursing Techniques." In the study, standardization was conducted in “care selection" by ultrasoundexamination.
The algorithms were targeted at individuals aged ≥18 years who have discomfort or needs related to defecation but do not always communicate them correctly, or who need assistance with defecation, such as patientswith spinal cord injuries.
Specifically, patients with cerebrovascular disease, brain dysfunction, impaired consciousness, dementia, spinal
cord injury, Parkinson's disease, patients with intractable diseases, and terminally-ill patients are assumed to be
those who have discomfort or need but are not always able to communicate their discomfort or need. In addition, individuals with sensory insensitivity of the rectum (e.g., due to aging) and those who have lost the strongurge to defecate due to continuous defecation suppression are also included.
The CQs in this guideline follow this algorithmic flow. The nurse confirms the presence or absence of suspected constipation from the patient's interview and defecation diary.
If constipation is suspected, the presence of bowel obstruction should be ruled out first. Bowel obstructionrefers to a physical blockage of the intestinal lumen caused by stool retention. The symptoms of bowel obstruction may include abdominal distention, abdominal pain, nausea/vomiting, and absence of bowel movements.

― 34 ―

Subjects
Patients who are not always able to communicate their discomfort or need for
defecation, or those who need assistance with defecation, such as patientswith a spinal cord injury.

Defecation diary
Medical history interview

Suspected
constipation orrectal fecal impaction

No

No defecation for >3 days
Hard stools
Very small volume of stools
Using laxatives

Yes or unknown
Physical Examination(inspection, auscultation, palpation, and percussion)

Symptoms
considered urgent andrequiring treatment

Acute abdomen
Gastrointestinal bleeding
Intestinal obstruction etc.

Yes

Report to physician

No
No

Constipation(Symptom)Yes or unknown
Rectal examination/rectal ultrasound observation

Follow-up
observation

RectumStool accumulation

No

Yes
RectumHard stool accumulation
Yes

No

Hard stool accumulationin the rectum

Stool accumulationin the rectum

No stool accumulationin the rectum

Defecation care to promotestool evacuation(Digital impaction, enema, etc.)

Defecation care to promotestool evacuation(Inducing self-defecation, etc.)

Defecation care to promoteintestinal peristalsis(Diet modiﬁcation, pharmacotherapy, etc.)

Observation by defecation diary and interview at least once a week
Note: If constipation cannot be determined despite the presence of fecal impaction basedon assessment results, the patient should be comprehensively evaluated, including otherassessment results, and followed up.

Figure 6: Algorithm for selecting nursing care based on constipation assessment― 35 ―

The physical signs may include increased peristalsis and metallic bowel sounds or decreased peristalsis by auscultation. The presence of these signs and symptoms is an indication for an abdominal X-ray or CT/MRI scan,
upon recommendation by the physician. The typical imaging signs of bowel obstruction are dilated bowel andbowel collapse distal to the site of obstruction.
If no complications are determined, a systematic physical examination (inspection, auscultation, palpation,and percussion) should be performed to identify signs related to constipation, and a digital rectal examination or
ultrasound imaging should be performed to rule out rectal fecal impaction.
In this systematic review of the guidelines, physical examination techniques included information obtained
from interviews with patient, caregivers, and family members. A constipation scale was also included. Examination techniques to detect rectal fecal impaction included digital rectal–anal examination and ultrasound imaging.
Since the above-mentioned assessments cannot necessarily determine the pathophysiology of constipation, a specialized defecatory function test is performed under the direction of a physician, if deemed necessary by the primary caregiver.

3) Assessment methodology(1) Interview 1)
Interview the patient, family members, or caregiver about symptoms, medical history, medication use, defecation patterns and environment related to defecation, warning signs, and risk factors.
The key aspects include frequency of defecation, stool characteristics, abdominal symptoms, and anal symptoms. The patient's medical history should include the duration of illness, onset of illness, comorbidities, medication use, history of surgery, and history of childbirth. Defecation patterns and the environment related to
defecation refer to the defecation rhythm, breakfast intake, toilet environment, and defecation posture. Dietaryfactors and any potential stressors should also be enquired.
Regarding warning signs and symptoms, the patient is asked about any sudden change in defecation habits,
unexpected weight loss (>3 kg within 6 months), bloody stools, fever, joint pain, and any abnormal physicalfindings (palpable abdominal mass, abdominal wave, palpable mass detected by digital rectal examination, bloodclots). Risk factors include onset of disease at the age of ≥50 years, and history or family history of colorectal
organic disease.
If warning symptoms or risk factors are present, necessary investigations for differential diagnosis of neoplastic
or inflammatory disease are performed under the physician's direction.
If there is a hard, large fecal plug (fecal embolus) blocking the anus, soft or liquid stool may leak out from thesides, or only the liquid component of the fecal plug may flow out, soiling the underwear and perianal area. In
this case, there is a risk that the patient will be incorrectly deemed as not being constipated.
(2) Defecation diary
The defecation diary is used to monitor the patient's defecation status and determine whether or not constipation is suspected. There is no standardized format for defecation diary. Different facilities or care providers may
use different formats depending on the ease of use. The items noted in the log include time of defecation, bowel
movement, stool consistency, volume of defecation, use of medications (laxatives, enemas, suppositories), andstool removal.
In general, constipation is evaluated based on the following criteria: defecation cycle of 3 days or more, stool
consistency is hard, stool volume is small, and there is a sensation of residual stool. Since direct observation of― 36 ―

stools and subjective symptoms such as a feeling of residual stools are not always available, a defecation cycle of 3days or longer is used as a guideline for judging the suspicion of constipation. As a precaution in recording, days
without a bowel movement should be noted as such, so that the patient can visually identify when a bowel
movement has occurred.
(3) Assessment of stool form, volume, etc.
①Bristol stool form scale: BSFS
The Bristol Stool Shape Scale 9-11) is widely used for objective assessment (Figure 7). Types 3 through 5 arehealthy feces, types 1 and 2 are constipated feces, and types 6 and 7 feces indicate diarrhea. It can be assumed
that the harder the stool is, the longer the transit time through the digestive tract, and the softer the stool is, theshorter the transit time.
②Assessment of stool volume
There is no uniform method for evaluating stool volume. Specifically, the various descriptions used are “verysmall amount, about the size of a quail egg, about the size of a chicken egg, about the size of a banana, a lot,"2)and “about adherence, about the size of rabbit feces, about the size of a quail egg, about the size of a chicken egg,
about the size of a banana, more than one banana, watery stool,"12) to name a few. There is also one paper 13) thatsets a guideline for the amount of stool according to its hardness, ranging from 1 (SS) to 5 (LL). In addition,
there is a King's Stool Chart 14) that uses a combination of stool hardness and stool volume, and a simplified
Cent Scale 15). In addition, the validity of the Gut-Mieru-Sheet®, which evaluates stool volume, stool color, andstool shape as a stool shape evaluation tool, has been reported 16, 17).

Type
1Separate hard lumps, like nuts (hard to pass)2

Sausage-shaped but lumpy

3

Like a sausage but with cracks on its surface

4

Like a sausage or snake, smooth and soft

5

Soft blobs with clear-cut edges (passed easily)

6

Fluﬀy pieces with ragged edges, a mushy stool

7

Watery, no solid pieces ENTIRELY LIQUID

Figure 7: Bristol stool form scale(O’Donnell LJD, et al. Br Med J 1990; 300: 439-440，Longstreth GF, et al. Gastroenterology 2006;
130: 1480-1491)― 37 ―

(4) Self-assessment chart for the presence and severity of constipation 18, 19)
There are several self-assessment tools, but we will discuss three that are commonly used.
①Constipation assessment scale (CAS)20)
It was developed to care for cancer patients who experience constipation as a side effect of opioids. The scaleconsists of the following 8 items: feeling of abdominal fullness or bloating, change in voiding volume, decreased
frequency of bowel movements, feeling of rectal contents filling up, anal pain during bowel movements, fewer
bowel movements, condition of stool, diarrhea or watery, and more. Each item is rated on a scale of 0 (no problem) to 2 (very problematic). The total score for the past week is calculated and it ranges from 0 to 1. Individuals
scoring ≥1 point are considered constipated.
Fukai et al. developed a Japanese version of the constipation rating scale and tested its reliability and validity
in healthy students 21), healthy elderly persons 22), and disabled elderly persons without dementia 22) (Table 3). Ascore of 5 or higher indicates constipation which should be considered a nursing problem. To make the scale
available to a variety of subjects, it is divided into three different time periods. Specifically, the LT version evaluates bowel movements over the past month (long term), the MT version evaluates bowel movements over the
past week (medium term), and the ST version evaluates bowel movements on the same day or over several days
(short term).

Table 3: Response form for Japanese version of constipation assessment scale version 2
Three choices
Questionnaire
ST version

MT version andLT version

1.Abdominal distension or bloating-None-A little-Very much

-None of the above-Sometimes-All the time

2.Change in amount of gas passed rectally-Normal or large-Less-Very little-Normal or large-Sometimes less
-Always less

3.Less frequent bowel movements-Normal or large-Less-Very little-Normal or large-less-Very little

4.Rectal fullness or pressure-Not at all-A little-Very much

-Not at all-Sometimes-All the time

5.Rectal pain with bowel movement-Not at all-A little-Very much

-Not at all-Sometimes-All the time

6.Smaller stool size

-Normal or large-Less-Very little-Normal or large-less-Very little

7.Urge but inability to pass stool-Easy to discharge-Slightly difficult to discharge-Very difficult to discharge-Very difficult to discharge-Sometimes difficult to discharge-Always difficult to discharge

8.Oozing liquid stool-None-A little-Very much

-None of the above-Sometimes-All the time

ST: short term (On the day or during the past few DAYS), MT: middle term (Past 1 week), LT: long term (Past 1 month)(Fukai K., et al. Nursing Research. 1995;28:209-216. (in Japanese))― 38 ―

②Constipation scoring system (CSS)23)
Constipation scoring system consists of 8 items: frequency of defecation, difficult or painful defecation, residual stool sensation, abdominal pain, time required for defecation, assistance in defecation, number of attempts to
defecate/24 hours, and duration of constipation (in years)(Table 4). All items, except for the defecation assistance item, are scored on a scale of 0 to 4, while the defecation assistance item is scored on a scale of 0 to 2. The
total CSS score range is from 0 to 30, and a total score of ≥15 indicates constipation.

Table 4: Constipation scoring system
Evaluation item

0

2

3

4

Frequency of bowel movements

1-2 times per 2 times per
1-2 daysweek

1

Once per week

Less than once per
weekLess than once
per month

Difficulty: painful evacuation effort

Never

Rarely(Lessthan once/
month)

Sometimes(MoreUsually(More than
than once/month but once/week but lessless than once/week) than once/day)

Always(Morethan once/day)Completeness: feeling incomplete
evacuation

Never

Rarely(Lessthan 1 time/
month)

Sometimes(MoreUsually(More than
than once/month but once/week but lessless than once/week) than once/day)

Always(Morethan 1 time/day)

Pain: abdominal pain

Never

Rarely(Lessthan 1 time/
month)

Sometimes(MoreUsually(More than
than once/month but once/week but lessless than once/week) than once/day)

Always(Morethan 1 time/day)

Time: minutes in lavatory per attempt Less than 5

5-9

10-19

20-29

More than 30

Assistance: type of assistanceWithout
assistance

Stimulative
laxatives

Digital assistance or
enema

-

-

Failure: unsuccessful attempts forevacuation per 24 hours

Never

1-3

4-6

7-9

More than 10

History: duration of constipation (yr)

0

1-5

6-10

11-20

More than 21

Total score (Minimum score, 0;
Maximum score, 30)(The Japanese Society of Wound, Ostomy, and Continence Management (edit). New Edition Excretory Care Guidebook. Shorinsha Inc., Tokyo, 2023.
(in Japanese))③Patient assessment of constipation ‒ symptom questionnaire (PAC- SYM)24, 25)
PAC-SYM was developed to assess the frequency and severity of chronic constipation. Patients self-assess thedegree of 12 symptoms experienced over the last 2 weeks: abdominal symptoms (4 items), rectal symptoms (3items), and defecation status (5 items). The severity is rated on a Likert scale ranging from 1 to 4 (0: absent, 1:
mild, 2: moderate, 3: severe, and 4: very severe), with a total score of 0–48. It has been used in Japan to evaluate
cancer patients with opioid-induced chronic constipation 26).
(5) Quality of life assessment
Disease-specific measures of quality of life for subjects with constipation symptoms include the Patient Assessment of Constipation Quality of Life (PAC-QOL)27) and the Constipation-related Quality of Life measure 28).
The reliability and validity of the Japanese version of PAC-QOL (JPAC-QOL) have been demonstrated (Table5)29). It is a 28-item questionnaire consisting of four constipation-related domains and their subscales, with a 5point scale ranging from “0: not at all" to “4: extremely" for symptoms in the past 2 weeks. Lower scores indicate a higher quality of life. Since only the 18th item is positive, we recommend changing this item to the following when using the questionnaire. “Did you feel that you did not have control over your situation?" Alternatively, one can choose to reverse the coding.

― 39 ―

Table 5: JPAC-QOL
Physical discomfort score
1.felt bloated to the point of bursting?
2.felt heavy because of your constipation?
3.felt any physical discomfort?
4. felt the need to have a bowl movement but not been able to?
Psychosocial discomfort score5.been embarrassed to be with other people?
6.been eating less and less because of not being able to have bowel movements?
7.had to be careful about what you eat?
8.had a decreased appetite?
9.been worried about not being able to choose what you eat (for example, at afriend's house)?
10.been embarrassed about staying in the bathroom for so long when you were away from home?
11.been embarrassed about having to go to the bathroom so often when you were away from home?
12.been worried about having to change your daily routine (for example, traveling, being away from home)?
Worries/concerns score13.felt irritable because of your condition?
14.been upset by your condition?
15.felt obsessed by your condition?
16.felt stressed by your condition?
17.felt less self-confident because of your condition?
18.felt in control of your situation?
19.been worried about not knowing when you are going to be able to have a bowel movement?
20.been worried about not being able to have a bowel movement?
21.been more and more bothered by not being able to have a bowel movement?
22.been worried that your condition will get worse?
23.felt that your body was not working properly?
Satisfaction score24.had fewer bowel movements than you would like?
25.satisfied with how often you have a bowel movement?
26.satisfied with the regularity of your bowel movements?
27.satisfied with the time it takes for food to pass through the intestines?
28.satisfied with your treatment?
Rate symptoms for the past 2 weeks on a 5-point scale from “0: not at all" to “4: extremely."
Lower scores indicate higher QOL (items 18 and 25–28 were reversed and tabulated in the analysis because lower scoresalso indicate lower QOL)
(Kira I. Journal of Japanese Society of Nursing Research. 2013;36:119-127. (in Japanese))(6) Physical examination
Inspection, auscultation, palpation, and percussion of the abdomen are performed in this order. On visual
examination, observe skin abnormalities (e.g., surgical scars), presence or absence of venous engorgement, external shape and contour of the abdomen (abdominal distention), surface movements (peristalsis), and position,color, tone, and shape of the umbilicus.
Auscultation is used to confirm the sound of bowel peristalsis. The observer should place the stethoscope
membrane over the right lower abdomen and listen for at least 1 minute. Normal peristalsis is heard irregularly
every 5 to 15 seconds. The nature of the sound varies with the contents, and it is also influenced by diet, defecation, and stress, therefore, it varies from person to person.
On percussion, a flatulence sound is heard in the intestinal tract, while a turbid sound is heard at sites of fecal
impaction. In case of increased intestinal peristalsis and gas retention, flatulence and percussion are increased,along with the increase in the number of resonant areas. If there is an intestinal obstruction or stricture, a metallic sound is heard, but a turbid sound may also be heard due to the retention of intestinal fluid or fecal masses
caused by obstruction.
On palpation, a fecal mass can be felt in the left lower abdominal quadrant (near the sigmoid colon) in constipated patients. A fecal mass in the sigmoid colon may be palpable even in thin individuals.

― 40 ―

(7) Rectal and anal visual examination, perianal palpation, and rectal and anal digital
examination
On visual examination, the anal area and the surrounding skin should be observed. Look for the presence andextent of perianal skin disorders, scarring, and deformities, and the presence and extent of anal looseness. Checkfor the presence of rectal prolapse, mucus or stool leakage, perineal prolapse, uterine prolapse, vaginal prolapse,
sentinel tag, and scarring. Observe the patient both at rest and while exerting intraabdominal pressure.
On palpation, observe the presence and degree of perianal skin induration and swelling, and the presence anddegree of tenderness. Rectal and anal digital examination should be performed to observe the presence orabsence of fecal mass and the state of contraction of the anal sphincter. The finger with which the rectoanal digital examination was performed should also be observed for any blood.
(8) Ultrasonography
In recent years, bedside ultrasound imaging to detect fecal impaction in the rectum is being increasingly performed 30).
For this examination, the subject adopts the supine position and the ultrasound probe is applied to the suprapubic border (Figure 8). In a transverse scan, the detection of a semilunar or crescent-shaped high echo area
located dorsal to the bladder is considered indicative of fecal mass accumulation in the rectum (Figure 9). If a
hard fecal mass is present, both a strong crescent-shaped high echo area and an acoustic shadow (AS) are
observed. If the crescent-shaped, strongly high echo area has a diameter of 4.5 cm or greater, a fecal embolus issuspected, as it is difficult to expel the stool by itself. A fecal embolus is a situation in which a large hard stool
occupies the rectum and cannot pass through the anus.
A transabdominal approach is generally utilized, but may not be possible in case of an empty urinary bladderor if there is a lot of gastrointestinal gas. In such cases, the transgluteal approach can be chosen 30). In the transgluteal approach, the subject is placed in a supine position with the knees flexed and the ultrasound probe isplaced over the gluteal cleft. As with the transabdominal approach, observation of a high echo area is considered
indicative of fecal impaction (Figure 10).

Figure 8: Ultrasound probe scanning during rectal observation(Ultrasound probe being applied to the suprapubic margin in a transverse scan.)― 41 ―

a：With stool retention

b：Hard stool retention

BalloonBladder

Bladder

Crescent-shapedHigh echo area

Crescent-shapedHigh echo area

Acoustic shadow

Acoustic shadow

Figure 9: Ultrasound image (transverse view) of fecal impaction in the rectumWith stool retention
排便ケアの体系

Anus

High echo area

Figure 10: Ultrasound scanning and ultrasound images in the transgluteal approach.

― 42 ―

4. Assessment-based nursing care
Assessment-based care includes care to promote stool mass evacuation, care to promote intestinal peristalsis,
and diet modification and pharmacotherapy.

1) Care to promote stool mass discharge(1) Digital impaction
Digital impaction is performed for patients who are unable to defecate spontaneously or who are unable toapply abdominal pressure, for example, due to paralysis or rectal–anal dysfunction. It is especially indicated forpatients with suspected fecal embolization and those with difficult-to-defecate constipation who fail to defecate
even after the use of suppositories and enemas. The procedure for digital impaction may lead to complications
such as bleeding due to damage to the rectal mucosa, perforation of the rectum, and hypotension due to vagal
reflex. Therefore, the procedure should be performed with extreme caution.
First, lubricate the gloved fingers with a lubricant. In the left lateral recumbent position, tap the anus with thefinger, and when the anus relaxes, insert the finger gently and slowly for 6 to 8 cm. Remove the stool clumps
from the rectal wall, and break up any large clumps before their removal.
(2) Enema, suppository
In the left lateral recumbent position, insert a tube and slowly inject a small amount of enema solution (up to
50 mL) warmed to approximately 40°C. In the case of fecal embolization (hard and large feces blocking theanus), stretching of the intestinal tract by the enema solution may cause bleeding or rectal perforation because of
decreased blood flow in the intestinal tract. In case of bleeding, glycerin may enter the blood vessels and cause
hemolysis, so the procedure should be performed with caution. In addition, in patients with age-related decline
in the external anal sphincter contractility or cognitive impairment, the patient may not be able to hold thebowel movement after injection leading to fecal incontinence.
There are two types of suppositories: suppositories that promote fecal evacuation by generating carbon dioxide in the rectum to increase the intrarectal pressure and suppositories that promote fecal evacuation by acting
directly on the rectal mucosa to promote peristalsis.
(3) Biofeedback
This method effectively reinforces training by using science and technology to convert invisible biologicalresponses into light, sound, and other forms, and by providing visual and auditory feedback of this information.
In practice, pelvic floor muscle dyscoordination is improved by teaching patients how to apply abdominal pressure when leaning forward and straining during defecation, and by making them aware of their anorectal movements using an anal electromyograph, an anal manometry, and a rectal balloon. The indication for biofeedback
is described in Evidence-based clinical practice guidelines for chronic constipation 2017 1) as functional defecation disorder due to pelvic floor muscle incoordination disorder. Pelvic floor muscle coordination disorder is acondition characterized by the failure of the pelvic floor muscles, including the puborectalis and anal sphincter
muscles, to relax properly during defecation.
A training method using electromyography biofeedback training equipment with a medical electromyographysystem for generating an anal electromyograph is used. To ensure that the abdominal muscles are sufficiently
contracted to increase abdominal pressure while simultaneously keeping the pelvic floor muscles relaxed without― 43 ―

contracting them, or for their proper guidance, one channel is used for the abdominal muscles and the other forthe pelvic floor muscles to simultaneously display and measure both surface electromyograms. When using ananal manometer, an anal pressure microtransducer is used, the sensor is inserted into the anus, and the actual
movement of the anal sphincter is monitored with the patient during training. When a rectal balloon is used,training is performed by inserting a balloon into the rectum and pushing it out as if it were a stool.
Biofeedback therapy is effective in the treatment of chronic constipation caused by pelvic floor muscle dyskinesia. However, because it is a highly specialized treatment, it should be performed at a specialized facility (Evidence-based clinical practice guidelines for chronic constipation 2023).
(4) Pelvic floor muscle exercises
Pelvic floor muscle exercises refer to pelvic floor muscle contraction training for the prevention and treatmentof urinary and fecal incontinence and pelvic organ prolapse. Pelvic floor muscle relaxation training in biofeedback therapy for pelvic floor muscle incoordination may have a secondary effect, but there is a lack of evidence
that it improves constipation 31).
(5) Transanal irrigation 2)
The common goal of forced defecation is periodic emptying of the colon, with an adequate amount of stool
expelled at once to eliminate residual stool. There are retrograde and progressive ablutions.
In retrograde colon irrigation, water injected through the anus is allowed to reach the cecum, with the goal of
excreting the entire colon content at once. Forced defecation, which is currently covered by insurance, is called“transanal self-irrigation," and is medically referred to as “transanal irrigation" or “retrograde colon irrigation." It
is a treatment to prevent fecal incontinence and improve constipation symptoms by injecting 300–1000 mL ofslightly warm water into the rectum transanally, once every 1–2 days, to enable evacuation of the contents of therectum and left-side colon as much as possible.
In Japan, the Peristine anal irrigation system was approved by the Japanese pharmaceutical affairs in 2016 foruse in transanal bowel cleansing therapy. The reimbursement has been approved for calculation as “hometransanal self-bowel cleansing instruction and management fee" since 2018, and an additional fee for materials
has been added since 2021. The indication for this treatment is defecation disorders caused by spinal cord disorders that do not improve sufficiently after more than three months of conservative treatment.
Antegrade continence enema, on the other hand, is performed by connecting an abdominal inlet to the colonand injecting enema solution into the ascending colon, to excrete feces from the entire colon at once. The
appendix is surgically separated from the cecum, that part is sutured, the appendix is reversed, and the distal side
is sutured through the submucosal tunnel of the cecum. The appendage is then placed in an anti-reflux mechanism, and one end of the appendage is placed as an inlet into a hole in the abdomen. Through this narrow passage, the colon can be accessed via a catheter. These procedures are sometimes performed by pediatric urologists
and surgeons for patients with spina bifida who require treatment in childhood.

2) Care to promote intestinal peristalsis(1) Lifestyle modification
The “Evidence-based clinical practice guidelines for chronic constipation 2017"1) recommend “appropriatediet, exercise, and abdominal wall massage" for improving symptoms of chronic constipation. Exercise therapy
for chronic constipation has been reported to be effective in improving symptoms, especially aerobic exercises 32).
In addition, abdominal wall massage 15 minutes a day, 5 times a week has been reported to be effective in relieving chronic constipation 33). Furthermore, although not mentioned in the aforementioned guidelines, warm

― 44 ―

compresses of the lower abdomen or back of the lumbar region have been reported to be effective in alleviating
chronic constipation 34, 35).

3) Diet modification and pharmacotherapy(1) Diet modification
The diet should include foods that soften the stool and stimulate bowel movements, such as insoluble fiber,soluble fiber, and fermented foods. Supplements should be prescribed to patients who have problems chewing or
swallowing and those who cannot consume sufficient amounts of food or fiber.
(2) Probiotics
Probiotics are defined as “live microorganisms that have a beneficial effect on the health of the host whentaken in appropriate amounts." The beneficial effects of probiotics are attributed to the improved hemostasis of
the intestinal microflora. According to the “Evidence-based clinical practice guidelines for chronic constipation
2023,"1) “certain probiotics are effective in increasing the frequency of defecation and improving abdominal
symptoms in patients with chronic constipation."(3) Pharmacotherapy
Also called laxatives. The type, action, and marketed generic names of each drug are summarized in Table 6.
References
1)
2)
3)
4)
5)
6)
7)
8)
9)
10)
11)
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14)
15)

16)
17)
18)

The Japanese Gastroenterological Association (edit). Evidence-Based Clinical Practice Guidelines for Chronic Constipation 2023. Nankodo Co., Ltd., Tokyo, 2023. (in Japanese)
The Japanese Society of Wound, Ostomy, and Continence Management (edit). New Edition Excretory Care Guidebook.
Shorinsha Inc., Tokyo, 2023. (in Japanese)
Anazawa S., et al (edit). Excretion Rehabilitation: Theoretical and Clinical. Nakayama Shoten Co., Ltd., Tokyo, 2009. (inJapanese)
Lembo A, Camiller M. Chronic constipation. N Engl J Med 2003; 349 (14): 1360-1368.
Matsumoto M, Misawa N, Tsuda M, et al. Expert consensus document: diagnosis for chronic constipation with faecal
retention in the rectum using ultrasonography. Diagnostics 2022; 12 (2): 300.
Comprehensive survey of living conditions 06 Statistical Tables (2nd Revision 0629) (mhlw.go.jp) (in Japanese)
Li J, Yuan M, Liu Y, et al. Incidence of constipation in stroke patients. A systematic review and meta-analysis. Medicine
2017; 96: e7225.
Hirano Y, et al. Survey of defecation status and laxative prescriptions in a group of convalescent beds. Expert Nurse 2004;
20 (10): 70-72.
OʼDonnell LJD, Virjee J, Heaton KW. Detection of pseudodiarrhoea by simple clinical assessment of intestinal transit
rate. Br Med J 1990; 300: 439-440.
Heaton KW, Radvan J, Cripps H, et al. Defecation frequency and timing, and stool form in the general population: aprospective study. Gut 1992; 33: 818-824.
Blake MR, Raker JM, Whelan K. Validity and reliability of the Bristol Stool Form Scale in healthy adults and patientswith diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther 2016; 44: 693-703.
Sakakibara C. Omakaseunchicchi, Mokuseisha, Fukuoka, 2019. (in Japanese)
Koyama A & Yokoyama Y. Case Report: Bowel Movements Care of Elderly Patients with Tube Feeding Living at Nursing Home. Jpn J Nutr Diet 2021; 79 (3): 151-161. (in Japanese)
Oyanagi N., et al. An attempt to unify the recognition of defecation volume and stool characteristics: Creation of a defecation scale chart. Best Nurse 2020; 31 (4): 58-45. (in Japanese)
Sato T & Abe H. Investigation of measures to standardize the expression of fecal characteristics and volume: Effects of theintroduction of the Bristol scale and the defecation volume scale. The 39th Nagano Prefectural Nursing Research Society
Proceedings. 23-26, 2019. (in Japanese)
Ohno H, Murakami H, Tanisawa K, et al. Validity of an observational assessment tool for multifaceted evaluation of faecal condition. Scientific Reports 2019; 9: 3760.
Ohno H., et al. Investigation of the reproducibility and validity of a questionnaire on usual bowel movement patterns andstool characteristics compared to an evacuation diary. Japanese journal of public health 2021; 68: 92-104. (in Japanese)
Mccrea GL, Miaskowski C, Sttotts NA, et al. Review article: self-report measures to evaluate constipation. Aliment Phar-― 45 ―

Table 6: Types of laxatives, actions, trade name/generic nameTypes of laxatives

Actions

Trade name/generic name

1. Probiotics

Improve the intestinal environment for goodbacteria(Trade names)Enteronon-R, Lac B-R, etc. (lactic acidbacteria)
Biofermin, Lac B (Bifidobacteria)
Mya BM (Butyric acid bacteria)

2. Inflammatory laxatives

A cellulose preparation that is indigestible byhuman digestive enzymes. It transfers water fromthe intestinal epithelium to the stools, increasesstool volume, and stimulates the intestinal tract toinduce peristalsis.

(Generic name)
Carboxymethylcellulose
Polycarbophil calcium

3. Osmotic laxative Saline laxatives

Salts, which are not easily absorbed from the(Generic name)intestine, increase osmotic pressure in the intestine, Magnesium oxidetransfer water from the intestinal epithelium
Magnesium citrate
to stools, increase stool volume, and stimulate
Magnesium hydroxide
peristalsis.
Magnesium sulfate

4. Stimulant
laxative

Saccharide
laxatives

Disaccharides, which are indigestible by humandigestive enzymes, increase osmotic pressure in
the intestines, transfer water from the intestinal
epithelium to stools, increase stool volume,
stimulate the intestinal tract, and cause peristalsis.

(Generic Name)
Lactulose
D-sorbitol
Lactitol

Infiltrating
laxative

Reduces the surface tension of stools by its
surfactant action and enables water to permeate
into hard stools with low water content.

(Generic name)
Dioctylsodium sulfosuccinate

Osmotic laxative(polymercompound)Aqueous solution, with special composition
electrolyte, mechanically cleanses the intestinal
tract.

(Generic name)Polyethylene glycol

Anthraquinones

Hydrolyzed by intestinal bacteria and enzymes(Generic name)in the digestive tract. It becomes active and acts
Sennosideon the intermuscular plexus of the large intestineSenna
to promote high amplitude colonic contraction
Aloe
waves, thereby inhibiting water absorption from the (Generic name)intestinal tract and causing a lucid laxative effect.
Bisacodyl

Diphenyl

Sodium picosulfate
5. Epithelial
Chloride channel A functional fatty acid compound that activates(Generic Name.)function altering activator
the CIC-2 chloride channel on the lumenal side
Lubiprostone
drugof the small intestine and stimulates osmotic water
secretion into the intestinal tract, thereby softening
the stool and boosting fecal transport in the small
intestinal tract to promote defecation
Guanylate cyclase Synthetic peptide consisting of 14 amino acids
C receptor
that increases the amount of cGMP in mesentericagonistepithelial cells via stimulation of the guanylate
cyclase C receptor. Increased cGMP promotes
intestinal fluid secretion via CFTR activation.

(Generic Name.)
Linaclotide

6. Gastroprokinetic 5-HT4 receptor
agent
stimulator

Selectively activates 5-HT receptors in the
Auerbach plexus within the gastrointestinal wall

This drug is unavailable in Japan

7. Kampo medicine

Varies with each Kampo drug

(Generic name)Daewang Ganoderma Tang, AsoninMaru, Daiken Zhong Tang, etc.

8. Bile acid transporter inhibitors

Inhibits bile acid absorption and increases water
secretion and colonic motility.

(Generic name)Elobixibat

Agonist: A drug that increases the action or expression when it binds to a receptor― 46 ―

19)
20)
21)
22)
23)
24)
25)
26)
27)
28)
29)
30)

31)

32)
33)
34)

35)

macol Ther 2008; 27: 638-648.
Sharma A, Rao SSC, Kearns K, et al. Review article: diagnosis, management and patient perspectives of the spectrum of
constipation disorders. Aliment Pharmacol Ther 2021; 53: 1250-1267.
McMillan SC, Williams FA. Validity and reliability of the constipation assessment scale. Cancer Nurs 1989; 12 (3): 183188.
Fukai K., et al. A Developmental Study of the Japanese Version of the Constipation Assessment Scale. Nursing Research
1995; 28: 201-207. (in Japanese)
Fukai K., et al. A Study of Bowel Habit in the Elderly by the Japanese Version of the Constipation Assessment Scale.
Nursing Research 1995; 28: 209-216. (in Japanese)
Agachan F, Chen T, Pfeifer J, et al. A constipation scoring system to simplify evaluation and management of constipatedpatients. Dis Colon Rectum 1996; 39: 681-685.
Frank L, Kleinman L, Farup C, et al. Psychometric validation of a constipation symptom assessment questionnaire. Scand
J Gastroenterol 1999; 34: 870-877.
Larsen MB, Bachmann HH, Søborg B, et al. Prevalence of self-reported abdominal symptoms among 50-74-years-old
men and women eligible for colorectal cancer screening: a cross-sectional study. BMC Cancer 2021; 21: 910.
Harada T, Imai H, Fumita S, et al. Opioid-induced constipation in patients with cancer pain in Japan (OIC-J study): a
post hoc subgroup analysis of patints with gastrointestinal cancer. Int J Clin Oncol 2021; 26: 104-110.
Marquis P, Lodge CDL, Dubois D, et al. Development and validation of the patient assessment of constipation quality oflife questionnaire. Scand J Gastroenterol 2005; 40: 540-541.
Wang JY, Hart SL, Lee J, et al. A valid and reliable measure of constipation -related quality of life. Dis Colon Rectum
2009; 52: 1434-1442.
Kira I. Validity and Reliability of a Japanese Version of the Patient Assessment of Constipation Quality of Life Questionnaire. Journal of Japanese Society of Nursing Research 2013; 36: 119-127. (in Japanese)
The Japanese Society of Wound, Ostomy, and Continence Management & the Society for Nursing Science and Engineering (edit). Best Practices for Observation of Rectal Fecal Retention by Ultrasonography. Shorinsha Inc., Tokyo, 2021.
(in Japanese)
Mimura T. Effectiveness of pelvic floor muscle exercises for constipation (Special feature: Clearly answer the questions
that concern you! Urinary and defecation care for urologic inpatients; Questions nurses feel about defecation care). Urological nursing 2013; 18: 40-44. (in Japanese)
Gao R, Tao Y, Zhou C, et al. Exercise therapy in patients with constipation: a systematic review and meta-analysis of randomized controlled trials. Scand J Gastroenterol 2019; 54 (2): 169-177.
Lämås K, Lindholm L, Stenlund H, et al. Effects of abdominal massage in management of constipation: a randomized
controlled trial. Int J Nurs Stud 2009; 46: 759-767.
Hosono K., et al. Effect of Lower Abdominal Warming on Bowel Movement in Elderly Patients with a Low Level ofConsciousness: Analysis Based on the Bristol Stool Scale and the Japanese Version of the Constipation Assessment ScaleShort Term. Japanese Journal of Nursing Art and Science 2012; 11 (3): 28-34. (in Japanese)
Kira I. Random control trial of hot compresses for women those who used laxatives on severity of constipation and qualityof life. Jpn J Nurs Sci 2016; 13: 95-104.

― 47 ―

Part 2.
Recommendation statements and systematic reviews for each CQ

1．CQ 1

CQ 1
Is a systematic assessment using defecation diaries and interviews useful in the evaluation of constipation in adult patients who are not always able to communicate their discomfort and need for defecation?
1) Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, a systematic assessment using a defecation diary, which isnoninvasive, and a medical interview is recommended.
Strength of recommendation▶Recommendation by the expert panel[Note] Although there is insufficient evidence to recommend a systematic assessment using defecation diaries and interviews, the panel committee decided tomake a recommendation based on expert opinion. Since patients themselves are
not always able to communicate, care should be taken to seek information fromfamily members and caregivers who understand the patient's daily life.

2) Background and aims
In adult patients who are not always able to communicate their discomfort and needs regarding defecation,systematic assessment using defecation diaries and questionnaires is useful for the evaluation, treatment, and careof constipation. However, the usefulness of systematic assessment using defecation diaries and questionnaires in
actual clinical practice is not clear because of the diversity of practitioners and contents. Therefore, we examined
the sensitivity and specificity of systematic assessment using defecation diaries and interviews based on domestic
and overseas literature.

3) Commentary
A systematic review was planned to assess the sensitivity and specificity of systematic assessment using defecation diaries and interviews. However, no relevant articles were identified in literature search. The “Clinicalguideline for abnormal bowel movements-Chronic constipation" (Japanese Society of Gastroenterology, 2023)
recommends the use of a questionnaire. However, no study was found to have investigated the sensitivity andspecificity for this CQ.
In clinical practice, systematic assessment using defecation diaries and questionnaires is an indispensable technique to identify patients with suspected constipation and to conduct subsequent physical examinations. However, it may be difficult to obtain accurate information from adults who are not always able to communicate
their discomfort and needs regarding defecation, and there is a risk of delay in treatment and care for constipation. In such cases, it is necessary to solicit information from family members, caregivers, or other persons who
understand the patient's daily life. In addition, the physical examinations listed in CQ2 below should also be
conducted to evaluate constipation. For specific questions and physical examination techniques, please refer to― 50 ―

Part 1: Constipation
In addition to the certainty of the evidence, the panel meeting to determine the recommendation primarily
discussed the balance of benefits and harms, the subject's sense of value for the primary outcome, cost, and feasibility. Defecation diaries and interviews are assessment methods already used in general practice. There is noneed for new equipment or facilities, and there is no extra cost involved. In addition, in the case of patients who
are not always able to communicate their discomfort or need, medical personnel or family members are likely tomaintain records. Therefore, it was judged that there would be a limited impact on the values, intentions, andwishes of the target patients or groups and that the burden would not be great. Furthermore, since the benefitsof correct classification outweigh the possible harms of incorrect classification, there is no impact on medical
inequity. Moreover, since the assessment method is already widely used in clinical practice, the reliability andfeasibility of the assessment were judged to be high.
The facilitating factor for the application of the clinical guideline is that the defecation diary/questionnaire isalready a widely used assessment method in clinical practice, and does not require the use of any special equipment. A limitation is that assessment by defecation diaries/questionnaires requires a certain level of educationand experience.
Given the above, despite insufficient evidence, a recommendation was decided by the panel committee basedon expert opinion.

4) Database search results
The keywords used were: Constipation, physical examination, physical assessment, defecation care. The following
databases were searched for articles published as of November 3, 2020: PubMed, Embase, Cochrane Database of Systematic Reviews, The Cochrane Library/CENTRAL, CINAHL, and ICHUSHI. A total of 27 papers were selectedfrom out of the 2013 papers in the primary screening, and no papers were selected after the secondary screening. The
database search strategy is presented in the Appendix.

― 51 ―

5) Literature search flowchart
PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =0 ）Records screened （1st Screening）（n =2013）

Records excluded（n =1986 ）Full-text articles assessed for eligibility（2nd Screening）（n =27）Full-text articles excluded,with reasons（n=27）

Studies included in qualitative synthesis（n =0）

Studies included in quantitative synthesis（meta-analysis）（n =0）

Figure 1: Literature search flowchart― 52 ―

2．CQ 2

CQ 2
Is systematic assessment using physical examination techniques (inspection, auscultation, palpation, and percussion) useful in the evaluation of constipation in adultpatients who are not always able to communicate their discomfort or need for bowel
movements?
1) Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is recommended that a systematic assessment be performed using noninvasive physical examination techniques (inspection, auscultation, palpation, and percussion).
Strength of recommendation▶Recommendation by the expert panel[Note] Although there is insufficient evidence to recommend an assessment using
physical examination techniques (inspection, auscultation, palpation, and percussion), the panel committee decided to make a recommendation based on expert
opinion.

2) Background and aims
It is unclear whether systematic assessment using physical examination techniques, a noninvasive procedure, isuseful in the evaluation of constipation. Therefore, we examined the usefulness of systematic assessment using
physical examination techniques for evaluating constipation in persons aged 18 years or older with suspected
constipation based on domestic and overseas literature.

3) Commentary
A systematic review was planned to evaluate the usefulness of physical examination techniques for the evaluation of constipation in adult patients who are not always able to communicate their discomfort or need for defecation. However, no relevant articles were obtained in literature search.
In addition to the certainty of the evidence, the panel meeting to determine the recommendation primarily
discussed the balance of benefits and harms, the subject's sense of value for the primary outcome, cost, and feasibility. Despite the lack of evidence, physical examination techniques for the evaluation of constipation are
already used in general practice. These are also useful for adult patients who are not always able to communicate
their discomfort or need for defecation. For specific physical examination techniques, please refer to Part 1:
Constipation.
Given the above, despite insufficient evidence, a recommendation was made by the panel committee based on
expert opinion.

― 53 ―

4) Database search results
Constipation, physical examination, physical assessment, and defecation care were used as keywords. The following databases were searched for articles published as of November 3, 2020: PubMed, Embase, Cochrane
Database of Systematic Reviews), The Cochrane Library/CENTRAL, CINAHL, and ICHUSHI. Thirty-four
papers were selected out of the 2013 papers retrieved in the primary screening. However, none of the papers
qualified the criteria in the secondary screening. The database search strategy is presented in the Appendix.

5) Literature search flowchart

PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =0）

Records screened （1st Screening）（n =2013）

Records excluded（n =1979）

Full-text articles assessed for eligibility（2nd Screening）（n =34）Full-text articles excluded,with reasons（n=34）

Studies included in qualitative synthesis（n =0）

Studies included in quantitative synthesis（meta-analysis）（n =0）

Figure 2: Literature search flowchart― 54 ―

3．CQ 3CQ 3
Is assessment by digital rectal examination useful in the evaluation of rectal fecal
impaction during constipation in adult patients who are not always able to communicate
their discomfort or need for defecation?
1) Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is strongly recommended that a digital rectal assessment
be performed to evaluate rectal fecal retention during constipation.
GRADE 1D (Strength of recommendation：strong，Certainty of evidence (strength)：very weak)[Note] Although there is insufficient evidence to recommend assessment by digital
rectal examination, we decided to recommend it based on expert opinion
because digital rectal examination can assess the presence or absence of stool
in the rectum and is a reference standard for other CQs. The target patients ofthis guideline may not always be able to communicate their discomfort or needregarding defecation. When performing digital rectal examination, due consideration should be given to the stress induced by the procedure due to feelings ofshame, pain, and discomfort.

2) Background and aims
Under normal conditions, when there is no bowel movement, the rectum is empty of feces, and feces are
retained in the gut proximal to the sigmoid colon. Occurrence of large peristalsis in the left semicolon causes
movement of the feces stored in the sigmoid colon to the rectum, stretching the rectal wall. The stretch stimulus
is transmitted to the cerebral cortex via the sacral nerve, causing a bowel movement. However, adult patients
who are not always able to communicate discomfort or need for defecation may not feel the presence of feces in
the rectum and constipation may be suspected. However, it is unclear whether assessment by digital rectal examination is useful in evaluating constipation. Therefore, we examined the sensitivity and specificity of the assessment by digital rectal examination in persons aged ≥18 years suspected of constipation without subjective symptoms based on domestic and overseas literature.

3) Commentary
The criterion for selecting evidence was randomized controlled trials. However, observational studies werealso eligible for inclusion if no studies met this criterion. Literature search did not identify any articles presenting
evidence for this CQ that met the criteria.
Impairment of one of the rectoanal functions results in the so-called “fecal emptying disorders" wherein therectum is unable to comfortably expel feces. In rectal hypoesthesia, the patient does not feel the urge to defecate― 55 ―

even if there is fecal matter in the rectum. In addition to hypoesthesia of the rectal wall itself, other causes
include increased rectal compliance and increased rectal capacity. In some cases, the patient does not feel theurge to defecate, resulting in decreased frequency of defecation and leakage of a small amount of fecal matterfrom the anus, resulting in leaky fecal incontinence. It often occurs in adults who are unable to complain of subjective symptoms.
Rectal digital examination has traditionally been performed as a method for assessing fecal retention/stool
characteristics. It provides objective information regarding the rectum, which cannot be assessed by informationfrom defecation diaries, interviews, or abdominal physical examination techniques.
In the panel meeting to determine the recommendation, in addition to the certainty of the evidence, the main
issues discussed were the balance of benefits and harms, the sense of value for the main outcome of the target
population, cost, and feasibility. Patients covered by this guideline may not always be able to communicate theirdiscomfort or need regarding defecation. When performing the digital rectal examination, the need for such an
examination should be determined from information in the defecation diary, interview, and per abdominal
physical examination. In addition, due consideration should be accorded to stress induced by the examination,such as embarrassment, pain, and discomfort.
Rectal digital examination is performed in the left lateral recumbent position using the index finger. Usually,
the rectum up to 6 to 8 cm from the anal verge can be examined. In patients with functional abnormalities of
the rectum, the rectum can be observed for distension and the presence of fecal impaction. It can also detectscarring, rectal stenosis, and neoplastic lesions that may cause defecation difficulty, but these assessments require
specialized education and skills in rectal examination (visual and finger examinations).
Therefore, despite insufficient evidence, the panel committee made a recommendation based on expert opinion.

4) Database search results
Constipation, Physical Examination, Physical Assessment, and Defecation Care were used as keywords.
The following databases were used: PubMed (through November 3, 2020), Embase (through November 3,2020), Cochrane Database of Systematic Reviews (through November 3, 2020), The Cochrane Library/CENTRAL (through November 3, 2020), CINAHL (until November 3, 2020), and ICHUSHI (until 2021). A totalof 162 articles were selected from the 2013 articles in the primary screening, and no article was selected in thesecondary screening. The database search strategy is presented in the Appendix.

― 56 ―

5) Literature search flowchart

PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =0）

Records screened （1st Screening）（n =2013）

Records excluded（n =1851）

Full-text articles assessed for eligibility（2nd Screening）（n =162）

Full-text articles excluded,with reasons（n=162）

Studies included in qualitative synthesis（n =0）

Studies included in quantitative synthesis（meta-analysis）（n =0）

Figure 3: Literature search flowchart― 57 ―

4．CQ 4CQ 4
Is the assessment of rectal stool retention by ultrasound imaging useful in the evaluation of constipation in adult patients who are not always able to communicate their discomfort or need for defecation?
1) Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is strongly recommended that rectal fecal impaction beassessed by ultrasound imaging to determine rectal fecal impaction.
GRADE 1C (Strength of recommendation：strong，Certainty of evidence (strength)：weak)[Note] It is assumed that the patient understands how constipation can beassessed by means of a medical interview, defecation diary, and physical examination techniques. Ultrasound imaging for the detection of rectal fecal impaction
should be performed by a nurse who has received specific training in this technique. In addition, the ultrasound imaging should be compatible with a convex
probe as a prerequisite for adequate rectal observation. The probe should havea frequency in the range of 3.5 to 5 MHz and a resolution level that can delineate the bladder, uterus/vagina, prostate, and rectum.

2) Background and aims
Ultrasound imaging for assessment of fecal impaction in the rectum is a noninvasive method. In particular,
portable ultrasound imaging have recently become widely available and can be easily used at the patient's bedsideor in home health care settings. Since the presence or absence of stool retention in the rectum can be confirmedon the spot, it is expected to be an objective assessment method for adult patients who may not always be able tocommunicate their discomfort or need for defecation. However, it is unclear whether assessment based on rectal
observation with ultrasound imaging is useful in assessing constipation. Therefore, we examined the sensitivity
and specificity of ultrasound imaging for the assessment of rectal contents based on domestic and overseas literature.

3) Commentary
After a systematic review, two case-control studies, one prospective cohort study, and four cross-sectional
studies were selected. The ultrasound imaging equipment used in each study was different. Image acquisition
and interpretation were performed by ultrasound technologists* or trained nurses. In addition, the site where theprobe was applied for image acquisition was the hallux valgus in addition to the lower abdomen. The sensitivity
and specificity of ultrasound imaging for detecting rectal fecal impaction in the selected references are described
below.

― 58 ―

＊Registered medical sonographer: A certification established by the Japan Society of Ultrasonics in
Medicine to certify the knowledge and skills necessary for ultrasonography and to improve ultrasound medicine and medical care. Certified as a Registered Nurse, Licensed Practical Nurse, ClinicalLaboratory Technician, and Radiologic Technologist as a professional medical examiner.

(1) Detection of constipation
One case report 1) and one cross-sectional study 2) were adopted as reference criteria. The pooled sensitivity
was 0.45 (95% confidence interval [CI]: 0.27–0.64) and specificity was 0.93 (95% CI: 0.77–0.99).
Although the study subjects had normal cognitive function and were able to report subjective symptoms, it
was determined that this did not affect the outcomes (sensitivity and specificity). Non-directness was “low (0)"and selection bias was unknown. Because some of the included studies did not adequately describe the evaluation of echographic images, the risk of bias was evaluated as “medium/suspicious (-1)," the sensitivity and specificity were varied and inconsistency was set to “medium/suspicious (-1)," and the noncertainty was set to “medium/suspicious (-1)" due to the small sample size. Based on the above, the certainty of evidence was assigned agrade of C (weak).
(2) Detection of rectal fecal impaction
One case report 3) and one cross-sectional study 4) were adopted as reference criteria. The pooled sensitivity
was 1.00 (95% CI: 0.87–1.00) and pooled specificity was 1.00 (95% CI: 0.48–1.00). Owing to the high sensitivity and specificity, the possibility that the ultrasound images were analyzed after the results of the bowel
movements were known cannot be ruled out.
Although the subjects included had normal cognitive function and were able to report subjective symptoms, it
was determined that this did not affect the outcome. Non-directness was “low (0)," as the included studies wererated as “uncertain" with respect to selection bias and the timing of ultrasound image assessment, and studies
whose reference criterion was the degree of adhesion with stool retention by excision. The risk of bias was set at“medium/suspicious (-1)," the sensitivity and specificity were not varied and inconsistency was set at “low (0),"and the imprecision was set at “medium/suspicious (-1)" due to the small sample size. Based on the above, thecertainty of evidence was assigned as “C" (weak).
(3) Detection of hard stools
Reference criteria were stool characteristics (Bristol Stool Shape Scale) type 1 (hard, colossal, rabbit-feces-like(difficult to defecate) stool) or type 2 (sausage-like but hard stool). One case report 1), four cross-sectional studies 4-7),
and one cohort study 2) qualified the criteria. A meta-analysis of six references was conducted. The sensitivity andspecificity of imaging finding of “crescent-shaped high echo areas with acoustic shadows" for indicating hardstools were 0.93 (95% CI: 0.63–0.99) and 0.81 (95% CI: 0.60–0.92), respectively. Furthermore, in a paper 7)that used rectal observation with an artificial intelligence (AI)-equipped ultrasound imaging system, the sensitivity was 0.86 (95% CI: 0.57–0.98) and specificity was 0.88 (95% CI: 0.64–0.99). In addition, the sensitivity andspecificity of rectal observation by the sonographer and AI-equipped ultrasound system were 1.00 (95% CI:
0.89–1.00) and 1.00 (95% CI: 0.72–1.00), respectively 7).
Non-directivity was set to “low (0)" because the subjects included those who could complain of subjective
symptoms, but this was not deemed to have affected the outcome. The risk of bias was set to “medium/suspicious (-1)" because it included studies with “unknown" selection bias and studies with “unknown" blinding of― 59 ―

index test and reference criteria. Inconsistency was set at “Medium/suspicious (-1)" due to variations in sensitivity and specificity. Inconsistency was set to “low (0)" because the total number of patients was more than 100.
Based on the above, the certainty of evidence was set at “C" (weak).
In addition to the certainty of the evidence, the panel meeting to determine the recommendation primarily
discussed the balance of benefits and harms, the subject's sense of value for the primary outcome, cost, and feasibility. Since a healthy state is one in which there is little or no stool or gas in the rectum, if stool is present in therectum, it should be expelled as soon as possible by appropriate means. The target audience for this guideline isadult patients who are not always able to communicate their discomfort or need for defecation. All panelists discussed the desirable benefits of ultrasound imaging to detect stool retention in the rectum. Negative reactions
such as patient embarrassment and time burden were discussed as undesirable effects. Although no studies haveinvestigated patient reactions to ultrasound examination, physicians and nurses who use ultrasound in their clinical practice for detecting rectal stool retention said that patients typically do not object to the use of ultrasoundfor this purpose. In addition, the procedure is not time-intensive and can be performed quickly. Regarding costand feasibility, the cost of purchasing an ultrasound imaging and the cost of training personnel for detection ofrectal fecal impaction were discussed. Although both of these costs are initial costs, it was decided to consider theweight of the disadvantage of the costs in determining the strength of the recommendation, since the maintenance costs involve purchase of relatively inexpensive consumables, such as echogel, and these costs are notdirectly borne by the patient.
Based on the above, the certainty of evidence is weak, but considering the benefit to the subject, and based on
the expert opinion, the recommendation and strength of evidence for this CQ is GRADE 1C (strength of recommendation: strong; certainty of evidence (strength): weak).

4) Database search results
Constipation, physical examination, physical assessment, defecation care were the keywords for literaturesearch. The following databases were searched for articles published as of November 3, 2020: PubMed, Embase,
Cochrane Database of Systematic Reviews, The Cochrane Library/CENTRAL, CINAHL, and ICHUSHI. As aresult, 65 articles were selected from the 2013 articles in the primary screening, and 7 articles were included after
the secondary screening. The database search strategy is presented in the Appendix.

― 60 ―

5) Literature search flowchart

PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =1）

Records screened （1st Screening）（n =2014）

Records excluded（n =1954）

Full-text articles assessed for eligibility（2nd Screening）（n =60）Full-text articles excluded,with reasons（n=53）

Studies included in qualitative synthesis（n =7）

Studies included in quantitative synthesis（meta-analysis）（n =6）

Figure 4: Literature search flowchart― 61 ―

6) Reference standards: BSFS, defecation cycle, digital impaction(1) List after secondary screening
Table 1: List after secondary screening
Reference
Documents

Research Designs

P

Index test

Matsumoto, 2018

Case series

3 elderly patients
admitted to a longterm care facility

Observation of stool BSFS, defecation cycle Sensitivity andshape by ultrasound and digital impaction
specificity for
imaging systemconstipation,
sensitivity andspecificity for hardstoolsTanaka, 2018

Cohort study

Inpatients 65 years
and older withconstipation

Observation of stool
shape evaluation by
ultrasound imaging
system: R3 isconstipation, R1,2 is
not constipation

Reference Standards

Defecation cycle: Lessbowel movement
frequency is considered
constipation, and therest is not constipationO

Sensitivity andspecificity of thepresence or absenceof constipation
Sensitivity andspecificity of theHard stools

BSFS: Bristol stool form scale(2) List of accepted papers
Table 2: List of included papers
AuthorTitle, refrence, year of publication, volume and page

Matsumoto M, Yabunaka K,
Tanaka S, et al

The evaluation of stored feces in elderly patients by ultrasonography: Three case studies. The
evaluation of stored feces in elderly patients by ultrasonography: Three case studies, Nippon Ronen
Igakkai Zasshi. Japanese Journal of Geriatrics 2018; 55 (4): 657-662.

Tanaka S, Tabunaka K,
Matsumoto M, et al

Fecal distribution changes using colorectal ultrasonography in older people with physical andcognitive impairment living in long-term care facilities: a longitudinal observational study. Healthcare(Basel) 2018; 6 (2): 55.

(3) Evidence evaluation of individual research
Table 3: Evidence evaluation of individual research
CQ

＊1

CQ4-1

＊2

Participant

Adult patients who are not always able tocommunicate their discomfort and needfor defecation

Index test

Observation of rectal stool retention by
ultrasound imaging

Control test

not speciﬁed

Reference standard

Bristol stool form scale, frequecy ofbowel movement, rectal and anal
digital examination

OutcomeSensitivity & speciﬁcity in assessment ofconstipation
Risk of bias*1

Study
Study

Reference Participant

designstandard

Matsumoto,2018

Tanaka,2018

ID

Each domain was ratedn in 3 levels; “high”, “low” and unclear”.
The summary was reﬂected in the body of evidence in 3 levels; “serious “, “unlikely”, and “none”.

Indirectness ＊ 1

Number of participants

selection

Index Reference Flow and Summary Partici- Index Reference
Summary＊2
test
standard timingpant
test standard

TP

FP

TN

FN

PrevaSensispeciAccuROC
95%CI
95%CI
95%CI
95%CI
95%CI
lence
tivity
ﬁcity
racy
AUC

BSFS,
frequecy
Case of bowel
series movement,
digitalimpaction

unclearunclearlowunclearunlikely

low

low

low

none

1

1

1

0

0.33

0.008,
1.00

1.00

0.025,
1.00

0.50

0.01,
0.99

0.67

0.09,
0.99

NA

NA

NA

frequecy
Cohortof bowelstudy
movement

unclearunclearlowlowunlikely

low

low

low

none

13

1

26

17

0.53

0.39,
0.66

0.43

0.25,
0.63

0.96

0.81,
1.00

0.68

0.55,
0.80

NA

NA

NA

BSFS: Bristol stool form scale, TP: true positive, FP: false positive, TN: true negative, FN: false negative, ROC: receiver operating characteristic curve, AUC: area under curve― 62 ―

P

(4) Evaluation of body of evidence
Table 4: Evaluation of body of evidence
CQ*1. Each domain was ratedn in 3 levels; “very serious (-2)”, “serious (-1)” and “non (0)”.
*2. Strength of evidence was rated on four levels; “strong (A)”, “moderate (B)”, “weak (C)”and “very weak (D)”.
*3. Importance is rated on a sale of 1 to 9, with higher scores indicating greater importance.

CQ4-1

Participant

Adult patients who are not always able to communicate theirdiscomfort and need for defecation

Index test Observation of rectal stool retention by ultrasound imaging
Control test not speciﬁed
Reference Bristol stool form scale, frequecy of bowel movement, rectal andstandard anal digital examinationbody of evidence

OutcomeNumber of participants

Studies(No. ofstudies)

Referencestandard

BSFS, frequency
Case
Sensitivity &report(1)， of bowel
speciﬁcity inmovement, rectal
crossassessment ofand anal digital
sectional
constipation
examination
study(1)OthersRisk of Inconsist- Impre- Indirect(publication
bias
ency
cision nessTPbias, etc)
1
1
1
1
*
*
*
*
*1

FP

FN

TN

ROC/
AccuspeciSensiPreva95%CI
95%CI
95%CI
95%CI
95%CI
AUC
racy
ﬁcity
tivity
lence

−1

2

17

27

0.52

−1

−1

0

0

14

0.38,
0.65

0.45

0.27,
0.64

0.93

0.77,
0.99

0.68

0.55,
0.80

NA

NA

P

Strength
Imporoftance
evidence
*3
2
*

NA

D

7.8

BSFS: Bristol stool form scale, TP: true positive, FP: false positive, TN: true negative, FN: false negative, ROC: receiver operating characteristic curve, AUC: area under curve(5) Qualitative systematic review
Table 5: Qualitative systematic review
4-1
CQ

Is the assessment of rectal stool retention by ultrasound imaging useful in the evaluation of
constipation in adult patients who are not always able to communicate their discomfort orneed for defecation?

P

Patients over 18 years of age who are not always able to communicate their discomfort or needregarding defecation.

I

Observation using ultrasound imaging system.

C

None

Clinical contexts

In assessing for constipation, first determine whether or not constipation is suspected by interview anddefecation diary, followed by observation and information gathering. Observation and information
gathering include assessment of constipation by observing abdominal and anal symptoms,
pathophysiology of the underlying disease, gastrointestinal function based on defecatory function tests
and imaging studies, defecatory movements, and lifestyle habits. Based on the evaluation, appropriate
defecation care is implemented. In recent years, observation using ultrasound imaging is becoming
more common in clinical practice as a means of evaluating fecal retention. This method evaluates thepresence or absence of stool retention and hard stools based on the presence or absence of hyperechoic or acoustic shadows.

01

True positive, true negative, suspicious positive, and false negative results in constipation identification(stool shape, defecation cycle, stool removal, glycerin enema).

Summary of Indirectness

Although the subjects included those who were able to report subjective symptoms without cognitive
decline, the non-directiveness was set to Low (0) because it was judged not to affect the outcome.

Summary of Bias Risk

Studies with unknown selection bias and studies with unknown timing of ultrasound image evaluation
were included, with a Medium/Suspicious (-1) risk of bias.

Inconsistency and Other
summaries

Sensitivity and specificity varied and inconsistency was rated as Medium/Suspicious (-1). Inconsistency
was rated as Medium/Suspicious (-1) due to small sample size.

Commentary̲CQ4̲hyo4.indd 1

2― 63 ―

7) Reference standards: digital impaction, enema, stool form
(1) List of secondary screenings
Table 6: List of secondary screenings
Reference
Documents

Research Designs

P

Index test

Reference Standards

O

Yabunaka, 2017

Case series

One female
with rectal fecal
impaction and one
male without rectal
retention

Ultrasound imaging

Stool extraction andglycerin enema

Defecation findings
on ultrasound images

Sano, 2020

Cross sectional
study

8 dialysis patientswith defecation
problems

Ultrasound imaging, BSFS
observation of stoolform

Sensitivity andspecificity for stool
retention (Group1-3)
and no stool
retention (Group4)
Sensitivity andspecificity for hardstool (BSFS divided
into 1 or otherwise)(2) List of included studies
Table 7: List of included studies
AuthorTitle, reference, year of publication, volume and page

Yabunaka K, Nakagami G,
Komagata K, et al

Ultrasonographic follow-up of functional chronic constipation in adults: a report of two cases. SAGE
Open Medical Case Reports. 2017; 5: 2050313X17694234.

Sano Y, Muto M, Urata K, et The study of faces property assessment with ultrasonogrphy: usefullness of lower rectumalassessment by intergluteal cleft approach scanning method. Japanese Journal of Medical UltrasoundTechnology. 2020; 45 (2): 168-174.

(3) Evidence evaluation of individual research
Table 8: Evidence evaluation of individual research
CQ*1. Each domain was ratedn in 3 levels; “high”, “low” and unclear”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “serious “, “unlikely”, and “none”.

CQ4-2
Adult patients who are notalways able to communicate theirdiscomfort and need for defecation

Participant

Index test

Observation of rectal stool retention
by ultrasound imaging

Control test

not speciﬁed

Reference standard

Bristol stool form scale, rectal
and anal digital examination,
implementation of glycerin enema

OutcomeSensitivity & speciﬁcity in assessment ofrectal stool retention
Risk of bias *1

Study

Indirectness *1

Number of participants

ID

Study
designReferencestandard

ParticiReference Flow and Summary Partici- Index Reference Summary
pant
Index test
standard timing*2
pant test standard*2
selection

TP

FP

TN

FN

ROC
AccuspeciSensiPreva95%CI
95%CI
95%CI
95%CI
95%CI
AUC
racy
ﬁcity
tivitylence

Yabunaka,
2017

case
series

BSFS, rectal
and anal
digitalexaminationunclearunclear

low

low

none

low

low

low

none

1

0

1

0

0.50

0.01,
0.99

1.00

0.031.00

1.00

0.030.031.00
1.00
1.00

NA

NA

NA

BSFS

unclearunclearhighunclearunlikely

low

low

low

none

26

0

4

0

0.87

0.69,
0.96

1.00

0.87,
1.00

1.00

0.88,
0.40,
1.00
1.00
1.00

NA

NA

NA

crossSano, 2020 sectional
study

BSFS: Bristol soot form scale, TP: true positive, FP: false positive, TN: true negative, FN: false negative, ROC: receiver operating characteristic curve, AUC: area under curve― 64 ―

P

(4) Evaluation of body of evidence
Table 9: Evaluation of body of evidence
CQ*1. Each domain was ratedn in 3 levels; “very serious (-2)”, “serious (-1)” and “non (0)”.
*2. Strength of evidence was rated on four levels; “strong (A)”, “moderate (B)”, “weak (C)”and “very weak (D)”.
*3. Importance is rated on a sale of 1 to 9, with higher scores indicating greater importance.

CQ4-2

Participant

Adult patients who are not always able to communicate theirdiscomfort and need for defecation

Index test Observation of rectal stool retention by ultrasound imaging
Control test not speciﬁed
Referencestandard

Bristol stool form scale, digital evacuation, Implementation ofglycerin enema

body of evidence

Number of participants

Studies(No. ofstudies)

OutcomeSensitivity &speciﬁcity inassessmentof rectal stool
retention

Referencestandard

OthersRisk of Inconsist- Impre- Indirect(publication
bias
ency
cision nessTPbias, etc)
1
1
1
1
*
*
*
*
*1

FP

FN

TN

ROC/
AccuspeciSensiPreva95%CI
95%CI
95%CI
95%CI
95%CI
AUC
racy
ﬁcity
tivity
lence

−1

0

0

5

0.84

BSFS, digitalCase
impaction,
series(1),Cross- Imlementationof glycerin
sectional
enema
study(1)

0

−1

0

0

27

0.67,
0.95

1.00

0.87,
1.00

1.00

0.89,
0.48,
1.00
1.00
1.00

NA

NA

P

Strength
Imporoftance
evidence
*3
2
*

NA

D

7.5

BSFS: Bristol stool form scale(5) Qualitative systematic review
Table 10: Qualitative systematic review
4-2
CQ

P

Is the assessment of rectal stool retention by ultrasound imaging useful in the evaluation of
constipation in adult patients who are not always able to communicate their discomfort orneed for defecation?

Patients over 18 years of age who are not always able to communicate their discomfort or needregarding defecation.

I

Observation using ultrasound equipment.

C

None.

Clinical contexts

In assessing for constipation, first determine whether or not constipation is suspected by interview anddefecation diary, followed by observation and information gathering. Observation and information
gathering include abdominal and anorectal symptoms, pathophysiology of the underlying disease, andgastrointestinal function through defecatory function tests and imaging studies, as well as defecatory
movements and lifestyle. Based on the classification of constipation, appropriate defecation careshould be provided. In recent years, observation using ultrasound equipment is becoming popular inclinical practice as one of the ways to evaluate fecal retention. This method evaluates the presence orabsence of fecal retention and hard stools based on the presence or absence of hyper-echogenicity or
acoustic shadows.

01

True positive, true negative, false positive, and false negative in rectal fecal impaction identification (stool extraction, glycerin enema, and stool shape).

Summary of Indirectness

Although the subjects did not have cognitive decline and may have included some who were able toreport subjective symptoms, it was determined that this would not affect the outcome, and the nondirectiveness was set to Low (0).

Summary of Bias Risk

Selection bias included studies that were unknown, studies that were uncertain about the timing of
echographic evaluation, and studies in which the reference criterion was stool removal and degree ofadhesion with stool retention. Therefore, the risk of bias was set at Medium/Suspicious (-1).

Inconsistency and Other
summaries

There was no variation in sensitivity and specificity, and inconsistency was considered Low (0). Dueto the small sample size, the imprecision was set as Medium/Doubtful (-1).

Commentary̲CQ4̲hyo9.indd 1

2― 65 ―

8) Reference standard: Hard stool (BSFS1 or 2)(1) List of secondary screenings
Table 11: List of secondary screenings
Reference
Documents

Research Designs

P

Index test

Matsumoto, 2018

Case series

3 elderly patients
admitted to a longterm care facility

Ultrasound Imaging BSFS
System (Hyperechoic
area)

Sensitivity andspecificity of hardstoolsYabunaka, 2018a

Cross sectional
study

Eleven healthy
adultsUltrasound imaging BSFS
system (Hyperechoic
area or acoustic
shadow)

Sensitivity andspecificity of hardstoolsYabunaka, 2018b

Cross sectional
study

32 elderly patients
admitted to a longterm care facility
and meeting thecriteria for chronic
constipation

Ultrasound imaging
system ( Transverse
sectional image:Hyperechoic
area with acoustic
shadows,
Longitudinal
image:Hyperechoic
area)

BSFS

Sensitivity andspecificity of hardstoolsTabnaka, 2018

Cohort study

Inpatients 65 yearsof age or older who
are able to takeoral intake and arescheduled to behospitalized for atleast one week

Ultrasound imaging BSFS
system (Hyperechoic
area or acoustic
shadow)

Sensitivity andspecificity of hardstoolsMatsumoto, 2020

Cross sectional
study

Inpatients 65 yearsof age or older who
are able to takeoral intake and arescheduled to behospitalized for atleast one week

Ultrasound Imaging BSFS
System (Hyperechoic
area with acoustic
shading)

Sensitivity andspecificity of hardstoolsSano, 2020

Cross sectional
study

8 dialysis patientswith defecation
problems

Ultrasound imaging BSFS
system (Hyperechoic
area or acoustic
shadow)

Sensitivity andspecificity of hardstools (BSFS1 orotherwise)

BSFS: Bristol stool form scale― 66 ―

Reference StandardsO(2) List of included papers
Table 12: List of included papers
Authors

Title, reference, year of publication, volume and page

Matsumoto M, Yabunaka K,
Tanaka S, et al

The evaluation of stored feces in elderly patients by ultrasonography: Three case studies. The
evaluation of stored feces in elderly patients by ultrasonography: Three case studies, Nippon Ronen
Igakkai Zasshi. Japanese Journal of Geriatrics 2018; 55 (4): 657-662.

Yabunaka K, Matsumoto M,
Yoshida M, et al

Assessment of rectal feces storage condition by a point-of-care pocket-size ultrasound device forhealthy adult subjects: A preliminary study. Drug Discov Ther 2018a; 12 (1): 42-46.

Yabunaka K, Nakagami G,
Komagata K, et al

Constipation in the elderly in a Japanese long-term medical facility: An ultrasonographic
investigation. Drug Discov Ther 2018b; 12 (4): 233-238.

Tanaka S, Yabunaka K,
Matsumoto M, et al

Fecal distribution changes using colorectal ultrasonography in older people with physical andcognitive impairment living in long-term care facilities: a longitudinal observational study. Healthcare(Basel) 2018; 6 (2): 55.

Matsumoto M, Tsutaoka T,
Nakagami G, et al

Deep learning-based classification of rectal fecal retention and analysis of fecal properties using
ultrasound images in older adult patients. Japan journal of nursing science. Jpn J Nursing Sci 2020;
17 (4): e12340.

Sano Y, Muto M, Urata K, et The study of faces property assessment with ultrasonogrphy: usefullness of lower rectumalassessment by intergluteal cleft approach scanning method. Japanese Journal of Medical UltrasoundTechnology. 2020; 45 (2): 168-174.

(3) Evaluation of evidence in individual studies
Table 13: Evaluation of evidence in individual studies
CQ

CQ4-3

Participant

Adult patients who are not always
able to communicate their discomfort
and need for defecation

Index test

Observation of rectal stool retention by
ultrasound imaging

Control test

not speciﬁed

Reference standard

Bristol stool form scaleSensitivity & speciﬁcity in assessment of hardstool

OutcomeRisk of bias *1

Indirectness *1

ParticiReference Flow andpant
Index test
standard
timingselection

Summary Partici- Index Reference Summary*2
panttest standard
*2

TP

FP

TN

FN

BSFS

unclearunclearunclearlowunlikely

low

low

low

none

1

1

1

0

0.33

0.01,
0.91

1

0.03,
1.00

0.5

0.01,
0.99

0.667

0.94,
0.99

NA

NA

NA

BSFS

unclearlowunclearlowunlikely

high

low

low

none

3

8

0

0

0.27

0.60,
0.61

1

0.29,
1.00

0

0.00,
0.37

0.273

0.60,
0.61

NA

NA

NA

2

0.53,
0.16
0.33

0.15,
0.6
0.95

0.76,
0.926
0.99

0.71,
0.875
0.96

NA

NA

NA

3

0.21,
0.33
0.47

0.60,
0.842
0.97

0.31,
0.474
0.64

0.46,
0.596
0.72

NA

NA

NA

0

0.27,
0.45
0.64

0.77,
1
1.00

0.64,
0.882
0.99

0.79,
0.935
0.99

NA

NA

NA

0

0.12,
0.27
0.46

0.63,
1
1.00

0.05,
0.182
0.40

0.23,
0.4
0.59

NA

NA

NA

Study
ID

Study
designReferencestandard

Matsumoto,2018

Case series

Yabunaka,
2018a

Cross-sectional
study

Yabunaka,
2018b

Cross-sectional
study

Tanaka,2018

Cohort study

Matumoto,
2020

Cross-sectional
study

Sano, 2020

Cross-sectional
study*1. Each domain was ratedn in 3 levels; “high”, “low” and unclear”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “serious “, “unlikely”, and “none”.

BSFS

BSFS

BSFS

BSFS

unclearunclearunclearunclearlowunclearlowunclearlowunclearlowunclear

low

low

low

low

unlikelyunlikelyunlikelyunlikely

low

low

low

low

low

low

low

low

low

low

low

low

Number of participants

none

none

none

none

3

16

14

8

2

20

2

18

25

18

15

4

ROC
AccuspeciSensiPreva95%CI
95%CI
95%CI
95%CI
95%CI
AUC
racy
ﬁcity
tivitylence

BSFS: Bristol soot form scale, TP: true positive, FP: false positive, TN: true negative, FN: false negative, ROC: receiver operating characteristic curve, AUC: area under curve― 67 ―

P

(4) Evaluation of body of evidence
Table 14: Evaluation of body of evidence
CQ*1. Each domain was ratedn in 3 levels; "very serious (-2)", "serious (-1)" and "non (0)".
*2. Strngth of evidence was rated on four levels; "strong (A)", "moderate (B)", "weak (C)"and "very weak (D)".
*3. Importance is rated on a sale of 1 to 9, with higher scores indicating greater importance.

CQ4-3

Participant

Adult patients who are not always able to communicate theirdiscomfort and need for defecation

Index test

Observation of rectal stool retention by ultrasound imaging

Control test not speciﬁed
Reference standard Bristol stool form scale

Number of participants

OutcomeOthersRisk of Inconsist- Impre- IndirectStudies
Reference(publication
bias
ency
cision ness
TP(No. of studies) standard
bias, etc)
1
1
1
1
*
*
*
*
*1

case series (1),Sensitivity &cross-sectional
speciﬁcity inassessment of study (4), cohort
study (1)hard stool

BSFS

−1

−1

0

0

0

45

FP

FN

TN

ROC/
AccuspeciSensiPreva95%CI
95%CI
95%CI
95%CI
95%CI
AUC
racy
ﬁcity
tivity
lence

51

5

63

0.31

0.24,
0.38

0.90

0.78,
0.97

0.55

P

Strength
Imporoftance
evidence
*3
*2

0.88
0.58,
0.46,
0.91
0.66
0.93,
0.73
0.65

C

7.5

BSFS: Bristol stool form scale, TP: true positive, FP: false positive, TN: true negative, FN: false negative, ROC: receiver operating characteristic curve, AUC: area under curve(5) Meta-analysis

TP

FP

FN

TN

Sensitivity（95%CI）

Speciﬁcity（95%CI）

Matsumoto 2018
Matsumoto 2020
Sano 2020
Tanaka 2018
Yabunaka 2018 a
Yabunaka 2018 b

1
14
8
16
3
3

0
2
7
20
1
2

0
0
0
3
0
2

2
15
15
18
7
25

1.00［0.03, 1.00］
1.00［0.77, 1.00］
1.00［0.63, 1.00］
0.84［0.60, 0.97］
1.00［0.29, 1.00］
0.60［0.15, 0.95］

1.00［0.16, 1.00］
0.88［0.64, 0.99］
0.68［0.45, 0.86］
0.47［0.31, 0.64］
0.88［0.47, 1.00］
0.93［0.76, 0.99］

Total

45

32

5

82

0.93［0.63, 0.99］

0.81［0.60, 0.92］

Study

0

Sensitivity（95%CI）

Speciﬁcity（95%CI）

0.2 0.4 0.6 0.8

0.2 0.4 0.6 0.8

101

Figure 5: Meta-analysis

Q4̲hyo14.indd 1

202― 68 ―

(6) Qualitative systematic review
Table 15: Qualitative systematic review
4-3
CQ

P

Is the assessment of rectal stool retention by ultrasound imaging useful in the evaluation of
constipation in adult patients who are not always able to communicate their discomfort orneed for defecation?

Patients over 18 years of age who are not always able to communicate their discomfort or needregarding defecation.

I

Observation using ultrasound imaging equipment.

C

None.

Clinical contexts

In assessing for constipation, first determine whether or not constipation is suspected by interview anddefecation diary, followed by observation and information gathering. Observation and information
gathering include abdominal and anorectal symptoms, pathophysiology of the underlying disease, andgastrointestinal function through defecatory function tests and imaging studies, as well as defecatory
movements and lifestyle. Based on the classification of constipation, appropriate defecation careshould be provided. In recent years, observation using ultrasound imaging is becoming popular inclinical practice as one of the methods to evaluate fecal retention. This method evaluates the presenceor absence of fecal retention and hard stools based on the presence or absence of hyper-echogenicity
or acoustic shadows.

01

True positive, true negative, false positive, and false negative in rectal fecal impaction identification(hard stool).

Summary of Indirectness

Although it was possible that some of the subjects had no cognitive decline and were able toreport subjective symptoms, it was determined that this would not affect the outcome and the nondirectiveness was set to Low (0).

Summary of Bias Risk

Selection bias included studies that were unknown, studies with unknown timings for evaluation ofultrasound imaging, and studies in which the reference criterion was the degree of adherence withstool retention by stool extraction, with a Medium/Suspicious (-1) risk of bias.

Inconsistency and Other
summaries

Sensitivity and specificity were set to Medium/Suspicious (-1) for Inconsistency due to variation insensitivity and specificity. Inconsistency was set as Low (0) because there were more than 100 total
cases.

Commentary

References
1)

2)

3)
4)

5)
6)
7)

Matsumoto M, Yabunaka K, Tanaka S, et al. The evaluation of stored feces in elderly patients by ultrasonography: Threecase studies. The evaluation of stored feces in elderly patients by ultrasonography: Three case studies, Nippon Ronen
Igakkai Zasshi. Japanese Journal of Geriatrics. 2018; 55 (4): 657-662.
Tanaka S, Yabunaka K, Matsumoto M, et al. Fecal distribution changes using colorectal ultrasonography in older people
with physical and cognitive impairment living in long-term care facilities: a longitudinal observational study. Healthcare(Basel) 2018; 6: 55.
Yabunaka K, Nakagami G, Komagata K, et al. Ultrasonographic follow-up of functional chronic constipation in adults: areport of two cases. SAGE Open Med Case Rep 2017; 5: 2050313X17694234.
Sano Y, Muto M, Urata K, et al. The study of faces property assessment with ultrasonogrphy: usefullness of lower rectum
assessment by intergluteal cleft approach scanning method. Japanese Journal of Medical Ultrasound Technology. 2020;
45 (2): 168-174.
Yabunaka K, Matsumoto M, Yoshida M, et al. Assessment of rectal feces storage condition by a point-of-care pocket-size
ultrasound device for healthy adult subjects: A preliminary study. Drug Discov Ther 2018a; 12: 42-46.
Yabunaka K, Nakagami G, Tabata K,et al. Constipation in the elderly in a Japanese long-term medical facility: an ultrasonographic investigation. Drug Discov Ther 2018b; 12: 233-238.
Matsumoto M, Tsutaoka T, Nakagami G, et al. Deep learning-based classification of rectal fecal retention and analysis offecal properties using ultrasound images in older adult patients. Jpn J Nurs Sci 2020; 17: e12340.

― 69 ―

5．CQ 5

CQ 5
Is defecation care based on systematic assessment using defecation diaries and interviews useful for improving patient outcomes in adult patients who are not always able
to communicate their discomfort and need regarding defecation?
1) Recommendation
We propose the implementation of defecation care based on systematic assessment using defecation diaries and interviews with adult patients who are notalways able to communicate their discomfort or need regarding defecation.
GRADE 2D (Strength of recommendation：week，
Certainty of evidence (strength)：very weak)[Note] Since patients themselves are not always able to communicate, care should
be taken to seek information from family members and caregivers who understand the patient's daily life.

2) Background and aims
In adult patients who are not always able to communicate their discomfort or need regarding defecation, defecation care based on systematic assessment using defecation diaries and interviews can help inform appropriate
drug therapy and lead to the selection of appropriate defecation care.
However, it is unclear whether defecation care based on systematic assessment using defecation diaries andinterviews contributes to improved patient outcomes. Therefore, we examined the usefulness of defecation carebased on systematic assessment using defecation diaries and interviews from the domestic and overseas literature.

3) Commentary
A systematic literature search regarding defecation care based on systematic assessment using defecation diaries
and interviews was conducted. After the systematic review, one prospective cohort study was selected for review.
The study population consisted of 52 patients (age range, 65–89 years) with chronic constipation and lower
urinary tract symptoms who were attending a gastroenterology or urology clinic. Chronic constipation was
defined as having less than three bowel movements per week and hard stools. The number of bowel movements
per week, time spent in the toilet per day, and six other symptoms related to urination were prospectively surveyed using a questionnaire. After the survey entry, a constipation treatment (oral medication) was prescribed.
The number of bowel movements per week showed a significant increase (p < 0.01) and the time spent in the
toilet per day decreased (p < 0.01) compared to before the start of constipation treatment. There was a significant improvement in the scoring for urgency, frequency, and burning sensation during urination (p < 0.01).
The purpose of this study is to examine the effect of treatment of constipation on lower urinary tract symptoms. Therefore, for all outcome measures, subjects were those who could report subjective symptoms, and outcomes were reported using self-reported questionnaires. Since the data from defecation diaries and question-― 70 ―

naires were measured as outcome data rather than being used for the intervention, and it is unclear whether theconstipation assessment methods differ before and after the intervention, the non-directiveness was set at “-1"
(medium/suspicious). This was a single-arm observational study with no control group. The amount of medication used to treat constipation was customized for each individual. The outcome was a self-reported questionnaire (once a month). The risk of bias was set as high “-2." Inconsistency was set to low “0" because only one
observational study was included. All the other studies were assigned a score of -2 (high) due to insufficient
power. From the above, the certainty of evidence was set as D (very weak).
In addition to the certainty of the evidence, the main issues discussed at the panel meeting to determine therecommendation were the balance of benefits and harms, the subject's sense of value for the main outcome, cost,and feasibility. Since defecation diaries and interviews are already used in general practice, there is essentially no
cost involved. In addition, it was determined that the burden would not be too great for patients who are notalways able to communicate their discomfort or need, although there is some variation in their values, intentions, and wishes regarding outcomes for themselves. Furthermore, the reliability and feasibility of the assessment method were judged to be high because the benefits of correct classification outweigh the possible harms ofincorrect classification, there is no impact on medical inequity, and the assessment method is already widely usedin clinical practice.
The facilitating factor for the application of the guideline is that the defecation diary/questionnaire is alreadywidely used in clinical practice, and this method does not require any special equipment. A potential limitationis that assessment requires a certain level of education and experience.
Based on the above, the strength of recommendation and evidence for this CQ is GRADE 2D (strength ofrecommendation: weak; certainty of evidence (strength): very low).

4) Database search results
Constipation, physical examination, physical assessment, defecation care were the keywords. The following
databases were searched for articles published as of November 3, 2020: PubMed, Embase, Cochrane Database of
Systematic Reviews, The Cochrane Library/ CENTRAL, CINAHL, and ICHUSHI. A total of 39 articles wereselected from 2013 articles in the primary screening, and one article was selected after the secondary screening.
The database search strategy is presented in the Appendix.

― 71 ―

5) Literature search flowchart
PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =0）

Records screened （1st Screening）（n =2013）

Records excluded（n =1974）

Full-text articles assessed for eligibility（2nd Screening）（n =39）Full-text articles excluded,with reasons（n=38）

Studies included in qualitative synthesis（n =1）

Studies included in quantitative synthesis（meta-analysis）（n =0）

Figure 6: Literature search flowchart6) List after secondary screening
Table 16: List of secondary screenings
Reference
Documents

Research Designs

P

I

Charach G, 2001

Cohort study

Patients 65-89 years
old with chronic
constipation andlower urinary tract
symptoms

Determination of
Before the start ofconstipation based
constipation treatment
on defecation
patterns (number ofbowel movements
per week, abdominal
bloating, time spentin the toilet per day)and treatment ofconstipation (oralmedication) basedon these patterns― 72 ―CO
Frequency of bowel
movements per
week, abdominal
bloating, andtime spent in thebathroom per day7) List of included papers
Table 17: List of included papers
AuthorTitle, reference, year of publication, volume, and page

Charach G, Greenstein A,
Rabinovich P, et al.

Alleviating constipation in the elderly improves lower urinary tract symptoms. Gerontology 2001; 47:
72-76.

8) Evaluation of the evidence in individuar studies
Table 18: Evaluation of the evidence in individuar studies
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ5Participant

Adult patients who are not always able to communicate theirdiscomfort and need for defecation

Intervention

Defecation care based on systematic assessment using
defecation diaries and interviews

Control

Defecation care based on conventional assessment for
constipation

OutcomeNo of deﬁcation per week
Risk of bias*1

Study

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/Standard
deviation (SD)

Indirectness*1

Mean
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete Insuﬃcient
diﬀerence/Diﬀerences
SumOther
Diﬀerences in outcome
InterStudy
Partici- Inter- Con- OutConmary response con- tude of maryoutocome confounding
Mean SD Standardized
in participant
maryMean SDbias
measurecare
ventiondesignpation vention trol come
trol
2
4
2
*
adjustdatamean diﬀerence:chracteristics*
gradient founders eﬀect *
ment
SMD

ID

Charach, Cohort
2001
study

−2

−2

−1

−1

−2

0

−2

0

0

0

0

−1

−2

−1

−1

−1

NA

NA NA

52

4.7 1.2

can not becaluculated9) Evaluation of body of evidence
Table 19: Evaluation of body of evidence
CQ

CQ5

Participant

Adult patients who are not always able tocommunicate their discomfort and need for defecation

Intervention

Defecation care based on systematic assessment using
defecation diaries and interviews

Control

defecation care based on conventional assessment for
constipation*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. Upgarade factor was described in 3 levels; “high(+2)”, “moderate (+1)” and “low (0)”.
*3. Thee were 4 levels of evidence strengths; “strong (A)”, “moderate (B)”, “weak (C) “, and “very weak (D)”.
*4. The importance ranged from 1to 9. The higher score indicated greater importance.

Body of evidence

OutcomeNo of deﬁcation Cohort study
per week(1)
abdominal
bloating

Number at risk/Mean/Standard deviation (SD)OthersStudy
Risk of Inconsist- Impre- IndirectUpgrade(publication
design/Control
bias
Mean
ency
cisionness
factorbias, etc)
Number of
group
1
1
1
1
*
*
*
*
*2
*1
studies

Cohort study(1)

SD

InterMeanventionSD

MeanStrengthdiﬀerence/of
SD 95％ CI
Stndardized
evidencemean diﬀerence:*3
SMD

Importance
*4

−2

0

−2

−1

−2

0

NA

NA

NA

52

4.7

1.2

NA

NA

NA

D

7

−2

0

−2

−1

−2

0

NA

NA

NA

52

5

9.6154

NA

NA

NA

D

6

SMB study: single-case, multiple-baseline study― 73 ―

SD

95% CIcancan
not be not becalucu- caluculated lated10) Qualitative systematic review
Table 20: Qualitative systematic review
CQ

5

Is defecation care based on systematic assessment using defecation diaries and interviews
useful for improving patient outcomes in adult patients who are not always able tocommunicate their discomfort and need regarding defecation?

P

Adults 18 years and older who cannot complain of subjective symptoms (cerebrovascular disease,brain damage, consciousness disorder, dementia, spinal injury, intractable disease, terminal stage,
etc.)

I

If defecation care is provided based on an evaluation using a defecation diary and medical interview.

C

Conventional observation of constipation only (or none).

Clinical contexts

01

The constipation treatment process is categorized as diagnostic (assessment). The first step in theassessment of constipation is to determine whether or not constipation is suspected by interview anddefecation diary. Next, observation and information gathering are conducted. During observationand information gathering, defecation is assessed by observing abdominal and anorectal symptoms,
pathophysiology of the underlying disease, gastrointestinal function through defecatory function
tests and imaging examinations, as well as defecatory movements and lifestyle habits. Appropriate
defecation care is provided based on the assessed classification of constipation.
Does defecation care based on the assessment by defecation diary and interview in adults who cannot
complain of subjective symptoms contribute to the improvement of patient outcomes?
Frequency of bowel movements/week

Summary of Indirectness

Subjects are those who can report subjective symptoms, and outcomes are reported using a self-reportquestionnaire. Since the data from the defecation diary/questionnaire were measured as outcome
data rather than being used for the intervention, and it is unclear whether the constipation assessment
method differed before and after the intervention, the non-directiveness was rated as Medium/
Suspicious (-1).

Summary of Bias Risk

This is a single group observational study with no control group. The amount of medication used totreat constipation was not protocolized and customized to the individual. The outcome is a self-reportquestionnaire (once a month), which may lead to recall bias. Based on the above, the risk of bias was
set at High (-2).

Inconsistency and Other
summaries

Inconsistency was set to Low (0) because the included study was a single observational study. Allothers were set to -2 (High) as underpowered.

Commentary02

abdominal bloating

Summary of Indirectness

Subjects are those who can report subjective symptoms, and outcomes are reported using a self-reportquestionnaire. Since the data from the defecation diary/questionnaire were measured as outcome
data rather than being used for the intervention, and it is unclear whether the constipation assessment
method differed before and after the intervention, the non-directiveness was rated as Medium/
Suspicious (-1).

Summary of Bias Risk

This is a single group observational study with no control group. The amount of medication used totreat constipation was not protocolized and customized to the individual. The outcome is a self-reportquestionnaire (once a month), which may lead to recall bias. Based on the above, the risk of bias was
set at High (-2).

Inconsistency and Other
summaries

Inconsistency was set to Low (0) because the included study was a single observational study. Allothers were set to -2 (High) as underpowered.

Commentary

References
1)

Charach G, Greenstein A, Rabinovich P, et al. Alleviating constipation in the elderly improves lower urinary tract symptoms. Gerontology 2001; 47: 72-76.

― 74 ―

6．CQ 6CQ 6
Is defecation care based on systematic assessment using physical examination techniques (inspection, auscultation, palpation, and percussion) useful for improving
patient outcomes in adult patients who are not always able to communicate their discomfort or need for defecation?
1) Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is recommended that defecation care be based on systematic assessment using abdominal physical examination techniques (inspection,
auscultation, palpation, and percussion).
Strength of recommendation▶Recommendation by the expert panel[Note] Although there is insufficient evidence to recommend defecation carebased on a systematic system assessment using physical examination techniques(inspection, auscultation, palpation, and percussion), the panel committee madethis recommendation based on expert opinion.

2) Background and aims
Physical examination techniques (inspection, auscultation, palpation, and percussion) for abdominal examination are performed in addition to the interview to assess constipation symptoms such as decreased bowel motility
and abdominal distension and to identify potential organic diseases such as cancer and gastrointestinal obstruction. Therefore, it is commonly used as a physical assessment for constipation.
However, the impact of defecation care based on assessment by physical examination techniques (inspection,
auscultation, palpation, and percussion) on patient outcomes has not been clarified. In this study, we examined
the usefulness of defecation care based on physical examination techniques (inspection, auscultation, palpation,and percussion) by nurses.

3) Commentary
The criterion for selecting evidence was randomized controlled trials. Observational studies were also eligible
for inclusion if no studies met the criterion. None of the articles retrieved on literature search presented evidence
for this CQ.
Thus, the panel meeting to determine the recommendation focused primarily on the balance of benefits andharms, the subject's sense of value for the primary outcome, cost, and feasibility. Per abdominal physical examination techniques include palpation for detection of abdominal distention and tenderness in the supine position,
percussion to assess flatulence, and auscultation of bowel sounds. These are commonly used to identify organic
disease and obstacles to stool evacuation. In addition, training in defecation care based on systematic assessment
using physical examination techniques is an integral part of basic nursing education. Physical examination does

― 75 ―

not cause patient discomfort or pain. However, the selection of physical examination techniques and assessmentbased defecation care may vary among individuals, such as experts and newcomers. Since the physical examination techniques are already a part of general physical examination, the feasibility of conducting a study with acontrol group is low.
Given the above, there is insufficient evidence to recommend care, but the panel committee made the recommendation based on expert opinion.

4) Database search results
The following keywords were used for literature search: Constipation, physical examination, physical assessment, defecation care. The following databases were searched: PubMed (until November 3, 2020), Embase(until November 3, 2020), Cochrane Database of Systematic Reviews (until November 3, 2020), The CochraneLibrary/ CENTRAL (until November 3, 2020), CINAHL (until November 3, 2020), and the Central Journalof Medicine (until 2021). A total of 110 articles were selected from the 2013 articles in the primary screening,
and no articles were selected after the secondary screening. The database search strategy is presented in the
Appendix.

5) Literature search flowchart

PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =0）

Records screened （1st Screening）（n =2013）

Records excluded（n =1903）

Full-text articles assessed for eligibility（2nd Screening）（n =110）Full-text articles excluded,with reasons（n=110）Studies included in qualitative synthesis（n =0）

Studies included in quantitative synthesis（meta-analysis）（n =0）

Figure 7: Literature search flowchart― 76 ―

4．CQ 7

CQ 7
Is defecation care based on the assessment by digital rectal examination useful for
improving patient outcomes in adult patients who are not always able to communicate
their discomfort or need for defecation?
1) Recommendation
Defecation care based on digital rectal examination is strongly recommended in
adult patients who are not always able to communicate their discomfort or needfor defecation.
GRADE 1D (Strength of recommendation：strong，Certainty of evidence (strength)：very weak)[Note] Although there is insufficient evidence to recommend assessment by digital
rectal examination, we decided to recommend it based on expert opinion
because it can enable the assessment of the presence or absence of stool in therectum and is a reference standard for other CQs. The target patients of thisguideline may not always be able to communicate their discomfort need regarding defecation. When performing digital rectal examination, due consideration
should be given to the stress induced by digital rectal examination due to feelings of shame, pain, and discomfort.

2) Background and aims
In the absence of bowel movement, the rectum is normally empty of feces, and the feces are stored on the oralside of the sigmoid colon. Occurrence of large peristalsis in the left semicolon causes propulsion of the fecesfrom the sigmoid colon to the rectum, stretching the rectal wall. The stretch stimulus is transmitted to the cerebral cortex via the sacral nerve, causing a bowel movement. However, adult patients, who are not always able tocommunicate discomfort or need for defecation, may not feel the presence of feces in the rectum and constipation may be suspected. In such cases, digital rectal examination can provide useful information regarding theneed for defecation care.

3) Commentary
The criterion for selecting evidence was randomized controlled trials. Observational studies were also eligible
for inclusion if no studies met the criterion. A systematic literature search did not identify any eligible articles
presenting evidence for this CQ.
Therefore, the panel meeting to determine the recommendation primarily discussed the balance of benefits
and harms, the subject's sense of value for the primary outcome, cost, and feasibility. It is unclear whether defecation care based on assessment by digital rectal examination to assess rectal fecal impaction during constipation
is useful in improving patient outcomes, but observation of rectal sensation and rectal reflexes by digital rectal― 77 ―

examination may be useful for guiding defecation care. In the absence of any evidence, the effectiveness and certainty of the evidence could not be evaluated. However, the feasibility of the intervention was considered highbecause it is already a commonly implemented intervention method. It is necessary to obtain adequate training
to ensure that it is performed safely without causing pain to the subject and that the necessary information onrectal sensation and reflexes is obtained.
Based on the above, there is insufficient evidence to recommend care, but the panel decided to make a recommendation based on expert opinion.

4) Database search results
The following keywords were used for the literature search: constipation, physical examination, physicalassessment, defecation care.
The following databases were searched: PubMed (until November 3, 2020), Embase (until November 3,2020), Cochrane Database of Systematic Reviews (until November 3, 2020), The Cochrane Library/ CENTRAL (until November 3, 2020), CINAHL (until November 3, 2020), and ICHUSHI (until 2021). A total of
8 papers were selected from 2013 papers in the primary screening, and no papers were selected after the secondary screening. The database search strategy is presented in the Appendix.

5) Literature search flowchart

PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =0）

Records screened （1st Screening）（n =2013）

Records excluded（n =2005）

Full-text articles assessed for eligibility（2nd Screening）（n =8）

Full-text articles excluded,with reasons（n=8）

Studies included in qualitative synthesis（n =0）

Studies included in quantitative synthesis（meta-analysis）（n =0）

Figure 8: Literature search flowchart― 78 ―

8．CQ 8CQ 8
Is defecation care based on observation of rectal stool retention by ultrasound imaging
useful for improving patient outcomes in adult patients who are not always able to communicate their discomfort and need for defecation?
1) Recommendation
In adult patients who are not always able to communicate their discomfort orneed for defecation, it is strongly recommended to implement defecation carebased on ultrasound imaging to detect rectal stool retention.
GRADE 1C (Strength of recommendation：strong，Certainty of evidence (strength)：weak)[Note] Ultrasound imaging should be performed by nurses trained in the observation of rectal fecal impaction. The ultrasound imaging should be compatible witha convex probe as a prerequisite for adequate rectal observation. The probeshould have a frequency in the range of 3.5 to 5 MHz and a resolution level thatcan delineate the bladder, uterus/vagina, prostate, and rectum.

2) Background and aims
In adult patients who are not always able to communicate their discomfort or need for defecation, it is usefulto use ultrasound imaging to observe the presence of stool retention in the rectum and provide appropriate medication and defecation care based on the results. However, it is unclear whether defecation care based on assessment using ultrasound imaging contributes to improved patient outcomes. Therefore, we examined the usefulness of defecation care based on ultrasound imaging findings from domestic and overseas literature.

3) Commentary
Systematic literature search identified one single-case, multiple-baseline study and one case report.
The former examined the effectiveness of an algorithm in which home health care nurses who had undergone
training added ultrasound imaging observations to traditional physical assessment and implemented care basedon the results of the observations 1).
In 15 home care patients, comparison of the baseline and intervention periods showed a significant reductionin the frequency of hard stools (p < 0.01), manual defecation (p < 0.01), stimulant laxative use (p < 0.01), andglycerin enema use (p = 0.04). The Tau-U of the intervention effect ranged from 0.34 to 0.56, suggesting amoderate change. In the latter case study, a home health care nurse who received educational program added
ultrasound imaging to the traditional physical assessment and provided care based on the observations to an 86year-old male prostate cancer patient who was being treated at home 2). Following the intervention, stool characteristics changed from hard stools (BSFS1) to normal stools (BSFS3-5), eliminating the need for stool removal,
and the patient was able to defecate on his own in the toilet after an enema. A meta-analysis could not be con-

― 79 ―

ducted because of the nature of the studies.
All outcome measures were reported by patients with the ability to report subjective symptoms. Therefore, it
was determined to have a non-directiveness of “low (0)," the risk of bias was rated as “medium/suspicious (-1)"
due to the home care nurse's knowledge of the echo results, inconsistency was rated as “low (0)" due to the small
number of articles, and imprecision was rated as “medium/suspicious (-1)." Based on the above, the certainty ofevidence was assigned as C (weak).
In addition to the certainty of the evidence, the main issues discussed at the panel meeting were the balance ofbenefits and harms, the subject's sense of value for the main outcome, cost, and feasibility. Since a healthy stateis one in which there is little or no stool or gas in the rectum, if stool is present in the rectum, it should be
expelled as soon as possible by appropriate means. The target population for this guideline is adult patients who
are not always able to communicate their discomfort or need for defecation, and all panelists discussed the desirable benefits of ultrasound imaging for detecting stool retention in the rectum. Negative reactions such as
patient embarrassment and time burden were discussed as undesirable effects. Although no papers had describe
patient reactions to ultrasound observation, physicians and nurses who use ultrasound in their clinical practice toobserve stool retention in the rectum reported that patients typically do not object to the use of ultrasound. In
addition, it was also commented that the procedure is not time-consuming. Regarding cost and feasibility, thepurchase cost of the ultrasound device and the cost of training in detecting rectal fecal impaction were discussed.
However, these are initial costs, and since the maintenance cost is relatively low (including relatively inexpensive
consumables such as echogel) and these costs are not directly borne by the patient, it was decided to consider theweight of the disadvantageous aspects of the costs when determining the strength of the recommendation.
Based on the above, although the certainty of the evidence is weak, the recommendation and strength of evidence for this CQ is GRADE 1C (strength of recommendation: strong; certainty of evidence (strength): weak)
based on the expert opinion, taking into consideration the benefit to the target population.

4) Database search results
Constipation, physical examination, physical assessment, defecation care were the keywords used for literaturesearch. The following databases were searched for articles published as of November 3, 2020: PubMed, Embase,
Cochrane Database of Systematic Reviews, The Cochrane Library/ CENTRAL, CINAHL, and ICHUSHI. A
total of 130 articles were selected from 2013 articles in the primary screening, and 2 articles were selected after
the secondary screening. The database search strategy is presented in the Appendix.

― 80 ―

5) Literature search flowchart

PubMedCENTRAL

IchushiEmbase

CINAHL

CDSR

1289

308

82

591

277

3

Total records identiﬁed throughdatabase searching（n = 2013）

Additional records identiﬁed throughother sources（n =0）

Records screened （1st Screening）（n =2013）

Records excluded（n =1883）

Full-text articles assessed for eligibility（2nd Screening）（n =130）

Full-text articles excluded,with reasons（n=128）Studies included in qualitative synthesis（n =2）

Studies included in quantitative synthesis（meta-analysis）（n =0）

Figure 9: Literature search flowchart― 81 ―

6) List of secondary screenings
Table 21: List of secondary screenings
Reference
Documents

Research Designs

P

I

C

O

Matsumoto M,
2020aSingle-case,multiple-baselinestudy

15 home carepatients Eligibility
criteria: (1)defecation difficulty
due to cognitive or
physical decline, (2)defecation intervalof 3 days or moreor BSFS 1 or 2
points, (3) low stool
volume, Exclusion
criteria: (1) nointention by thepatient or family tochange defecationcare, (2) historyof organic bowel
disease, (3) risk of
bleeding from thecolon

Defecation carebased also on
assessment with theaddition of rectal
fecal impaction
observation by
ultrasound imaging
to the physicalexamination

Defecation care basedon assessment of
medical interview andphysical examination

Number of nonmanual defecation(per week)
Number of hardstools (BSFS12) defecation (perweek)
Number of manual
defecation (perweek)
Number of manual
defecations (perweek)
Stimulant laxativeuse (per week)
Glycerin enema use(per week)
Amount ofsuppositories used(per week)

Matsumoto M,
2020bCase report

85 years old,
prostate cancer,
recovering at home

Defecation carebased also on
assessment with theaddition of rectalstool retention
observation by
ultrasound imaging
to the physicalexamination

Defecation care basedon the assessment of
medical interview andphysical examination

BSFS (median)
Number of stool
extractions
Amount of osmotic
laxatives used
Amount of glycerinenema used

BSFS: Bristol stool form scale

7) List of included papers
Table 22: List of included papers
AuthorTitle, reference, year of publication, volume, and page

Matsumoto M, Yoshida M,
Yabunaka K, et al

Safety and efficacy of a defecation care algorithm based on ultrasonographic bowel observation in
Japanese home-care settings: a single-case, multiple-baseline study. Geriatr Gerontol Int 2020a; 20:
187-194.

Matsumoto M, Yabunaka K,
Yoshida M, et al

Improvement of constipation symptoms in an older adult patient by defecation care based on usinga handheld ultrasound device in home care settings: a case report. J Wound Ostomy Continence
Nurs 2020b; 47: 75-78.

― 82 ―

8) Evaluation of the evidence in individuar studies(1) Outcome: Score of Bristrol stool form scale
Table 23: Evaluation of the evidence in individuar studies - Score of Bristrol stool form scale
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-1

Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

OutcomeScore of Bristrol stool form scale
Risk of bias *1

Study

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete
Diﬀerences
SumOtherconDiﬀerences outcome
InterStudy
Partici- Inter- Con- OutConmary response con- tude of maryoutocome
Mean SD
in participant
maryMean SD
founding bias
measurein careventiondesignpation vention trol come
trol
*2
data
chracteristics*2
gradient founders eﬀect *4
adjustment

IDMatsumoto Case
M，2020b report

0

0

−2

0

0

0

−1

0

0

0

0

−1

0

0

0

0

2

1.00

0

8

Mean diﬀerence/
Standardized
mean diﬀerence:
SMD

3.70 0.35

SD

95% CIcancan
not be not becalucu- caluculated lated

2.7(2) Outcome: Number of non-manual defecations
Table 24: Evaluation of the evidence in individuar studies - Number of non-manual defecations
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-2

Participant

Adult patients who are not always able to communicate theirdiscomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool retention
by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

OutcomeNumber of non-artiﬁcial defecation per week
Risk of bias *1

Study

ID

Selection
bias

Performancebias

Diﬀerences
DiﬀerencesStudy
in participant
in caredesignchracteristics

Matsumoto SMB
M, 2020a
Study

0

0

Detection
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete
SumOtherconoutcome
Partici- Inter- Con- OutConmary response con- tude of maryoutocome
mary
Mean SDbias
founding
measurepation vention trol come
trol
*2
data
*2
gradient founders eﬀect *4
adjust
ment

−2

−1

0

0

−1

0

0

0

0

−1

0

0

0

0

69

1.25 1.94

InterMean SD
vention73

1.85 1.86

Mean diﬀerence/
Standardized
mean diﬀerence:
SMD

0.60

SD 95% CI

0.32[-0.03,-1.23]

SMB study: single-case, multiple-baseline study̲hyo3̲ブリストル.indd 1― 83 ―

2024/0yo5̲硬便.indd 1(3) Outcome: Frequency of hard stool defecation
Table 25: Evaluation of the evidence in individuar studies - Frequency of hard stool defecation
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-3Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

Outcomez

Number of hard stool defecation per week
Risk of bias *1

Study

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete
Diﬀerences
SumOtherconDiﬀerences outcome
Study
Partici- Inter- Con- OutConmary response con- tude of maryoutocomein participant
maryMean SD
founding bias
measurein caredesignpation vention trol come
trol
*2
data
chracteristics*2
gradient founders eﬀect *4
adjustment

IDMatsumoto SMB
M, 2020a
Study

0

0

−2

−1

0

0

−1

0

0

0

0

−1

0

0

0

0

69

0.59 0.94

InterMean SD
vention73

0.18 0.51

Mean diﬀerence/
Standardized
mean diﬀerence:
SMD− 0.41

SD 95% CI

0.16[-0.66,-0.16]

SMB study: single-case, multiple-baseline study(4) Outcome: Number of bowel movement
Table 26: Evaluation of the evidence in individuar studies - Number of bowel movement
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-4Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

OutcomeNumber of artiﬁcial defecation per week
Risk of bias *1

Study

ID

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete
Diﬀerences
SumOtherconDiﬀerences outcome
Study
Partici- Inter- Con- OutConmary response con- tude of maryoutocomein participant
maryMean SD
founding bias
measurein caredesignpation vention trol come
trol
*2
data
chracteristics*2
gradient founders eﬀect *4
adjustment

InterMean SD
ventionMean diﬀerence/
Standardized
mean diﬀerence:
SMD

SD 95% CI

Matsumoto SMB
M, 2020a
Study

0

0

−2

−1

−1

0

−1

0

0

0

0

−1

0

0

−1

0

69

1.46 1.03

73

0.88 0.96

-0.58

0.11

[-0.91,-0.25]

Matsumoto Case
M, 2020b report

0

0

−2

0

−1

0

−1

0

0

0

0

−1

0

0

0

0

2

3.00 0.00

8

0.38 0.48

-2.63

0.12

can
not becaluculated

SMB study: single-case, multiple-baseline study― 84 ―

2024/01/

(5) Outcome: Amount of non-stimulant laxatives
Table 27: Evaluation of the evidence in individuar studies - Amount of non-stimulant laxatives
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-5Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

OutcomeAmount of non-stimulant laxative per week (mg)
Risk of bias *1

Study

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete
SumDiﬀerences
Other
conDiﬀerences outcome
Partici- Inter- Con- OutConmary response con- tude of maryoutocomemary
MeanStudy design in participant
founding bias
measurein carepation vention trol come
trol
*2
data
*2
chracteristics
gradient founders eﬀect *4
adjustment

IDMatsumotoM, 2020a

SMB
Study

MatsumotoCase report
M, 2020b

SD

InterMeanventionSD

Mean diﬀerence/
Standardized
mean diﬀerence:
SMD

SD

95% CI

0

0

−2

−1

−1

0

−1

0

0

0

0

−1

0

0

0

0

69 3589 3609

76

4041 4304

452.0

434.5

[-836.98,
1740.98]

0

0

−2

0

−1

0

−1

0

0

0

0

−1

0

0

0

0

2

8

1680 62.09

265.5

493.7

[128.42,403.58]1414 94.29(6) Outcome: Amount of stimulant laxative
Table 28: Evaluation of the evidence in individuar studies - Amount of stimulant laxativeCQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-6Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

OutcomeAmount of stimulant laxative per week (mg)
Risk of bias *1

Study

ID

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete
Diﬀerences
SumOtherconDiﬀerences outcome
Study
Partici- Inter- Con- OutConmary response con- tude of maryoutocomein participant
maryMean SD
founding bias
measurein caredesignpation vention trol come
trol
*2
data
chracteristics*2
gradient founders eﬀect *4
adjustment

Matsumoto SMB
M, 2020a
study

0

0

−2

−1

−1

0

−1

0

0

0

SMB study: single-case, multiple-baseline study― 85 ―

0

−1

0

0

0

0

69

22.7 44.6

InterMean SD
vention76

14.1 34.2

Mean diﬀerence/
Standardized
mean diﬀerence:
SMD

SD

95% CI

− 8.6

3.92

[-21.63,4.43]

̲浣腸.indd 1(7) Outcome: Amount of glycerin enema
Table 29: Evaluation of the evidence in individuar studies - Amount of glycerin enema
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-7Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

OutcomeAmount of glycerin enema per wek (ml)Risk of bias *1

Study

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersID

Number at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible MagniIncomolete
Diﬀerences
Other
conDiﬀerences outcome
Studymary response conoutocome
tude ofin participant
founding bias
measurein caredesign*2
data
chracteristics
gradient founders eﬀect
adjustment

SumSumPartici- Inter- Con- OutConmary
mary
Mean
pation vention trol come
trol
*4
*2

SD

InterMean SD
ventionMean diﬀerence/
Standardized
mean diﬀerence:
SMD

SD

95% CI[-33.11,
6.91]

Matsumoto SMB
M, 2020a
Study

0

0

−2

−1

−1

0

−1

0

0

0

0

−1

0

0

0

0

69

58.3

62.1

73

45.2 59.4− 13.1

7.48

Matsumoto Case
M, 2020b report

0

0

−2

0

−1

0

−1

0

0

0

0

−1

0

0

0

0

2

180.0

0

8

97.5 59.5− 82.5

計算
計算不可
不可

SMB study: single-case, multiple-baseline study(8) Outcome: Amount of suppository
Table 30: Evaluation of the evidence in individuar studies - Amount of suppository
CQ*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. The summary was reﬂected in the body of evidence in 3 levels; “high (-2)”, “moderate (-1)”, and “low(0)”.
*3. Each domain was rated in 3 levels; “high (+2), “moderate (+1) , “low (0)”.
*4. The summary wsd refrected in the body of evidence in 3 levels; “high (+2) “, “moderate (+1) “, “low (0)”.

CQ8-8Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

Defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

Defecation care based on conventional assessment for
constipation

OutcomeAmount of suppository per wek (mg)
Risk of bias *1

Study

ID

Selection
bias

Performance Detection
bias
bias

Attrition
bias

Upgrade factor *3

OthersNumber at risk/Mean/
Standard deviation (SD)

Indirectness *1

Insuﬃcient
Inadequate
Sum- Dose- Plausible Magni- SumIncomolete
Diﬀerences
SumOtherconDiﬀerences outcome
Study
Partici- Inter- Con- OutConmary response con- tude of maryoutocomein participant
mary
Mean
founding bias
measurein caredesignpation vention trol come
trol
*2
data
chracteristics*2
gradient founders eﬀect *4
adjustment

Matsumoto SMB
M, 2020a
Study

0

0

−2

−1

−1

0

−1

0

0

0

0

−1

0

0

0

0

69

0.36

SD

1.22

InterMean SD
vention79

0.16 0.61

Mean diﬀerence/
Standardized
mean diﬀerence:
SMD− 0.20SD 95% CI

0.15[-0.52,0.12]

SMB study: single-case, multiple-baseline study― 86 ―
2024/01/10

̲CQ8̲hyo11.indd 19) Evaluation of body of evidence
Table 31: Evaluation of body of evidence
CQ

CQ8

Participant

Adult patients who are not always able to communicate
their discomfort and need for defecation

Intervention

defecation care based on observation of rectal stool
retention by ultrasound imaging

Control

defecation care based on conventional assessment for
constipation

Body of evidence

Outcome*1. Each domain was ratedn in 3 levels; “high(-2)”, “moderate/suspected (-1)” and “low (0)”.
*2. Upgarade factor was described in 3 levels; “high(+2)”, “moderate (+1)” and “low (0)”.
*3. Thee were 4 levels of evidence strengths; “strong (A)”, “moderate (B)”, “weak (C) “, and “very weak (D)”.
*4. The importance ranged from 1to 9. The higher score indicated greater importance.

Number at risk/Mean/Standard deviation (SD)OthersStudy
Risk of Inconsist- Impre- IndirectUpgrade(Publication
design/bias
ency
cisionness
factor Control
bias, etc.)
Number
1
1
1
1
*
*
*
*
*2
1
*
of studies

Mean

SD

Intervention

Mean

SD

Mean diﬀerence/
Stndardized mean
diﬀerence: SMD

SD

95％ CI

Strengthofevidence*3

Importance*4

Score of Bristol
Casestool form
report(1)
scale

−1

0

−1

0

0

0

2

1.00

0

8

3.70

0.35

2.70

NA

NA

C

7.4

Number of
SMB
non-artiﬁcial
defecation per study(1)
week

−1

0

−1

0

0

0

69

1.25

1.94

73

1.85

1.86

0.60

0.32

[ − 0.03,
1.23]

C

7.4

SMB
study(1),Casereport(1)

−1

0

−1

0

0

0

69

0.59

0.94

73

0.18

0.51

− 0.420.16[ − 0.66,− 0.16]

C

7.4

SMB
Numberstudy(1),of artiﬁcial
Case
defecation perreport(1)
week

−1

0

−1

0

0

0

71

1.50

1.05

81

0.83

0.94

− 0.670.16[ − 0.91,− 0.25]C

7

SMB
Amount ofnon-stimulant study(1),Caselaxative per
week (mg) report(1)

−1

0

−1

0

0

0

71

3527.73 35756

84

3816.1 4152.2

288.37657.7[131.29,404.90]C

6.4

Amount ofstimulant
laxative per
week (mg)SMB
study(1)

−1

0

−1

0

0

0

69

22.7

44.6

76

14.1

34.2

− 8.603.92[ − 21.63,
4.43]

C

6.4

SMB
Amount ofstudy(1),glycerin enema
Case
per wek (ml)report(1)

−1

0

−1

0

0

0

71

61.7

64.4

81

50.4

61.4

− 11.30

10.21[ − 33.11,
6.91]

C

6.5

Amount ofsuppository
per wek (mg)

−1

0

−1

0

0

0

69

0.36

1.22

79

0.16

0.61

− 0.200.15[ − 0.52,
0.12]

C

6.5

Number of
hard stool
defecation
per week

SMB
study(1)SMB study: single-case, multiple-baseline study― 87 ―210) Qualitative systematic review
Table 32: Qualitative systematic review
CQ8

Is defecation care based on observation of rectal stool retention by ultrasound imaging usefulfor improving patient outcomes in adult patients who are not always able to communicate theirdiscomfort and need for defecation?

P

Adult patients who are not always able to communicate their discomfort or need regarding defecation.

I

Defecation care based on observation using ultrasound imaging equipment.

C

Defecation care based on medical interview and physical examination.

Clinical contexts

01

In assessing for constipation, first determine whether or not constipation is suspected by interview anddefecation diary, followed by observation and information gathering. Observation and information
gathering include abdominal and anorectal symptoms, pathophysiology of the underlying disease,and gastrointestinal function through defecatory function tests and imaging examinations, as well
as defecatory movements and lifestyle. Based on the classification of constipation, appropriate
defecation care should be provided. In recent years, observation using ultrasound imaging is
becoming popular in clinical practice as one of the methods to evaluate fecal retention. This method
evaluates the presence or absence of fecal retention and hard stools based on the presence or absenceof hyper-echogenicity and acoustic shadows.
Bristol stool form scale scores.

Summary of Indirectness

Subjects can report subjective symptoms, which may affect outcomes somewhat. Judged Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, it could warp the observations of the stool shape,
resulting in a detection bias. The patient was judged to be Medium/Suspicious (-1).

Inconsistency and Other
summaries

Inconsistency was determined to be Low (0) due to only one literature. The sample size was small
and the imprecision was judged to be Medium/Suspicious (-1).

Commentary02

Number of non-manual defecations.

Summary of Indirectness

Patients who can report subjective symptoms are included, which may affect outcomes somewhat. It
was determined to be Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, she might intentionally encourage non-usefuldefecation, which would be a detection bias. The patient was judged to be Medium/Suspicious (-1).

Inconsistency and Other
summaries

Inconsistency was determined to be Low (0) due to only one literature. The sample size was small,and inconsistency was judged as Medium/Suspicious (-1).

Commentary
03

Frequency of hard stool defecation.

Summary of Indirectness

Patients who can report subjective symptoms are included, which may affect outcomes somewhat. It
was determined to be Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, it could warp the observations of the stool
condition, resulting in a detection bias. The patient was judged to be Medium/Suspicious (-1).

Inconsistency and Other
summaries

Inconsistency was determined to be Low (0) due to only one literature. The sample size was small
and the imprecision was judged to be Medium/Suspicious (-1).

Commentary04

Number of bowel movement

Summary of Indirectness

Patients who can report subjective symptoms were included, which may affect the outcome somewhat.
In addition, one literature review included manual defecation, including suppositories and enemas inaddition to bowel movements, which was judged to be Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, she might intentionally reduce the number ofstool samples, which would be a detection bias. The patient was judged to be Medium/Suspicious (-1).

Inconsistency and Other
summaries

In both of the two references, the number of bowel movements tended to decrease in theintervention group, and the inconsistency was determined to be Low (0). The sample size was small,and inconsistency was judged to be Medium/Suspicious (-1).

Commentary― 88 ―

Table 32: Qualitative systematic review
05

Amount of non-stimulant laxatives

Summary of Indirectness

Patients who can report subjective symptoms are included, which may affect outcomes somewhat.
It was determined to be Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, she might intentionally increase the nonstimulant laxative, which would be a detection bias. The patient was judged to be Medium/
Suspicious (-1).

Inconsistency and Other
summaries

In both of the two references, the use of non-stimulant laxatives showed an increasing trend in theintervention group and was judged to be Low (0) for inconsistency. The sample size was small, andinconsistency was judged to be Medium/Suspicious (-1).

Commentary
06

Amount of stimulant laxative

Summary of Indirectness

Patients who can report subjective symptoms are included, which may affect outcomes somewhat.
It was determined to be Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, there is a possibility of intentionally reducing
the stimulant laxative, which would result in a detection bias. The patient was judged to be Medium/
Suspicious (-1).

Inconsistency and Other
summaries

Only one literature was found, and the inconsistency was determined to be Low (0). The sample
size was small, and the imprecision was judged to be Medium/Suspicious (-1).

Commentary07

Amount of glycerin enema

Summary of Summary ofIndirectness

Patients who can report subjective symptoms are included, which may affect outcomes somewhat.
It was determined to be Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, there is a possibility of intentionally reducing
the use of enemas, which would result in a detection bias. The patient was judged to be Medium/
Suspicious (-1).

Inconsistency and Other
summaries

In both of the two references, the amount of enema use tended to decrease in the intervention
group, and inconsistency was judged to be Low (0). Due to the small sample size, inconsistency was
judged to be Medium/Suspicious (-1).

Commentary08

Amount of suppository

Summary of Indirectness

Patients who can report subjective symptoms are included, which may affect outcomes somewhat.
It was determined to be Low (0).

Summary of Bias Risk

If the home care nurse knew the results of the echo, there is a possibility of intentionally reducing
the use of suppositories, which is a detection bias. The patient was judged to be Medium/Suspicious(-1).

Inconsistency and Other
summaries

Only one literature was found, and the inconsistency was determined to be Low (0). The sample
size was small, and the imprecision was judged to be Medium/Suspicious (-1).

Commentary

References
1)

2)

Matsumoto M, Yoshida M, Yabunaka K, et al. Safety and efficacy of a defecation care algorithm based on ultrasonographic bowel observation in Japanese home-care settings: a single-case, multiple-baseline study. Geriatr Gerontol Int 2020a;
20: 187-194.
Matsumoto M, Yabunaka K, Yoshida M, et al. Improvement of constipation symptoms in an older adult patient by defecation care based on using a handheld ultrasound device in home care settings: a case report. J Wound Ostomy Continence Nurs 2020b; 47: 75-78.

― 89 ―

Appendix

1. Key clinical issues

Key clinical issue 1
Key clinical issues addreses in the scope
Key clinical issue 1: Is it useful to conduct a systemic assement of colonic stool retention during constipation for adults who are notalways able to communicate their discomfort and need for defecation, using a defecation diary and interview?
Components of CQ
P (Patients,Problem,Population)
Gendernot specified

Ageover 18 years old

Dieases andconditions

adults who are not always able to communicate their discomfort and need for defecation

Geographic
requirements

not specified

Othersnot specified
I (Interventions) /C (Comparisons,Controls) list

I: systemic assessment using a defecation diary and interview
C: observayion of conventional constipation, or none
Outcomes are adopted with a score 5 or more.
O (Outcomes) list
OutcomeBenefit or harm

Priority

Included or excluded

O1

Sensitivity and specificity of constipation
identification

Benefit

7.8

◯

O2

Sensitivity and specificity of colonic stool
retention

Benefit

7.5

◯

O3

Stool form

Benefit

7.4

◯

O4

Feeling of imcomlete defecation

Benefit

7.1

◯

O5

Patient satisfaction

Benefit

7.1

◯

O6

Number of bowel movement (ferequency
or times/week)

Benefit7◯

O7

Diarhearia

Benefit

6.8

◯

O8

Number of digital evacuaion

Benefit

6.8

◯

O9

Amount of stool

Benefit

6.6

◯

O10

Pain during bowel movement

Benefit

6.6

◯

O11

Amount of laxative (oral medicine)Benefit

6.5

◯

O12

Amount of laxative (suppository or enema)

Benefit

6.5

◯

O13

Number of successful defecation attempts

Benefit

6.5

◯

O14

Abdominal pain

Benefit

6.4

◯

O15

Sensation of abdominal distension

Benefit6◯

O16

Time required for bowel movement

Benefit

5.9◯

CQ
CQ 1: Is a systematic assessment using defecation diaries and interviews useful in the evaluation of constipation in adult patients who
are not always able to communicate their discomfort and need for defecation?
CQ 5: Is defecation care based on systematic assessment using defecation diaries and interviews useful for improving patient outcomesin adult patients who are not always able to communicate their discomfort and need regarding defecation?

― 92 ―

Key clinical issue 2
Key clinical issues addreses in the scope
Key clinical issue 2: Is it useful to conduct a systemic physical assement of colonic stool retention during constipation for adults
who are not always able to communicate their discomfort and need for defecation, using inspection, auscultation, palpation, andpercussion?
Components of CQ
P (Patients,Problem,Population)
Gendernot specified

Ageover 18 years old

Dieases andconditions

adults who are not always able to communicate their discomfort and need for defecation

Geographic
requirements

not specified

Othersnot specified
I (Interventions) /C (Comparisons,Controls) list

I: systemic physical assessment using inspection, auscultation, palpation, and percussion
C: observayion of conventional constipation, or none
Outcomes are adopted with a score 5 or more.
O (Outcomes) list
OutcomeBenefit or harm

Priority

Included or excluded

O1

Sensitivity and specificity of constipation
identification

Benefit

7.8

◯

O2

Sensitivity and specificity of colonic stool
retention

Benefit

7.5

◯

O3

Stool form

Benefit

7.4

◯

O4

Feelings of imcomlete detecation

Benefit

7.1

◯

O5

Patient satisfaction

Benefit

7.1

◯

O6

Number of bowel movement (ferequency
or times/week)

Benefit7◯

O7

Diarhearia

Benefit

6.8

◯

O8

Number of digital evacuaion

Benefit

6.8

◯

O9

Amount of stool

Benefit

6.6

◯

O10

Pain during bowel movement

Benefit

6.6

◯

O11

Amount of laxative (oral medicine)Benefit

6.5

◯

O12

Amount of laxative (suppository or enema)

Benefit

6.5

◯

O13

Number of successful defecation attempts

Benefit

6.5

◯

O14

Abdominal pain

Benefit

6.4

◯

O15

Sensation of abdominal distension

Benefit6◯

O16

Time required for bowel movement

Benefit

5.9◯

CQ
CQ 2: Is systematic assessment using physical examination techniques (inspection, auscultation, palpation, and percussion) usefulin the evaluation of constipation in adult patients who are not always able to communicate their discomfort or need for bowel
movements?
CQ 6: Is defecation care based on systematic assessment using physical examination techniques (inspection, auscultation, palpation,and percussion) useful for improving patient outcomes in adult patients who are not always able to communicate their discomfort orneed for defecation?

― 93 ―

Key clinical issue 3
Key clinical issues addreses in the scope
Key clinical issue 3: Is it useful to conduct a digital rectal examination for rectal stool retention during constipation for adults who are
not always able to communicate their discomfort and need for defecationn?
Components of CQ
P (Patients,Problem,Population)
Gendernot specified

Ageover 18 years old

Dieases andconditions

adults who are not always able to communicate their discomfort and need for defecation

Geographic
requirements

not specified

Othersnot specified
I (Interventions) /C (Comparisons,Controls) list

I: digital rectal examination
C: observation of conventional constipation, or none
Outcomes are adopted with a score 5 or more.
O (Outcomes) list
OutcomeBenefit or harm

Priority

Included or excluded

O1

Sensitivity and specificity of constipation
identification

Benefit

7.8

◯

O2

Sensitivity and specificity of colonic stool
retention

Benefit

7.5

◯

O3

Stool form

Benefit

7.4

◯

O4

Feelings of imcomlete defecation

Benefit

7.1

◯

O5

Patient satisfaction

Benefit

7.1

◯

O6

Number of bowel movement (ferequency
or times/week)

Benefit7◯

O7

Diarhearia

Benefit

6.8

◯

O8

Number of digital evacuaion

Benefit

6.8

◯

O9

Amount of stool

Benefit

6.6

◯

O10

Pain during bowel movement

Benefit

6.6

◯

O11

Amount of laxative (oral medicine)Benefit

6.5

◯

O12

Amount of laxative (suppository or enema)

Benefit

6.5

◯

O13

Number of successful defecation attempts

Benefit

6.5

◯

O14

Abdominal pain

Benefit

6.4

◯

O15

Sensation of abdominal distension

Benefit6◯

O16

Time required for bowel movement

Benefit

5.9◯

CQ
CQ 3: Is assessment by digital rectal examination useful in the evaluation of rectal fecal impaction during constipation in adult patients
who are not always able to communicate their discomfort or need for defecation?
CQ 7: Is defecation care based on the assessment by digital rectal examination useful for improving patient outcomes in adult patients
who are not always able to communicate their discomfort or need for defecation?

― 94 ―

Key clinical issue 4
Key clinical issues addreses in the scope
Key clinical issue 4: Is it useful to conduct a observation using ultrasonography for rectal stool retention during constipation for adults
who are not always able to communicate their discomfort and need for defecation?
Components of CQ
P (Patients,Problem,Population)
Gendernot specified

Ageover 18 years old

Dieases andconditions

adults who are not always able to communicate their discomfort and need for defecationcommunicate

Geographic
requirements

not specified

Othersnot specified
I (Interventions) /C (Comparisons,Controls) list

I: observation using ultrasonography
C: observation of conventional constipation, or none
Outcomes are adopted with a score 5 or more.
O (Outcomes) list
OutcomeBenefit or harm

Priority

Included or excluded

O1

Sensitivity and specificity of constipation
identification

Benefit

7.8

◯

O2

Sensitivity and specificity of colonic stool
retention

Benefit

7.5

◯

O3

Stool form

Benefit

7.4

◯

O4

Feelings of imcomlete defecation

Benefit

7.4

◯

O5

Patient satisfaction

Benefit

7.1

◯

O6

Number of bowel movement (ferequency
or times/week)

Benefit7◯

O7

Diarhearia

Benefit

6.8

◯

O8

Number of digital evacuaion

Benefit

6.6

◯

O9

Amount of stool

Benefit

6.6

◯

O10

Pain during bowel movement

Benefit

6.6

◯

O11

Amount of laxative (oral medicine)Benefit

6.5

◯

O12

Amount of laxative (suppository or enema)

Benefit

6.5

◯

O13

Number of successful defecation attempts

Benefit

6.4

◯

O14

Abdominal pain

Benefit

6.4

◯

O15

Sensation of abdominal distension

Benefit

6.3

◯

O16

Time required for bowel movement

Benefit

6.3◯

CQ
CQ 4: Is the assessment of rectal stool retention by ultrasound imaging useful in the evaluation of constipation in adult patients who
are not always able to communicate their discomfort or need for defecation?
CQ 8: Is defecation care based on observation of rectal stool retention by ultrasound imaging useful for improving patient outcomesin adult patients who are not always able to communicate their discomfort and need for defecation?

― 95 ―

2. Database search formula

PubMed, CINAHL, Cochrane Library#1"defecation"[MeSH Terms] OR "defaecat*"[Title/Abstract] OR "defecat*"[Title/Abstract] OR "dyschezia"[Title/Abstract]
OR "hard stool*"[Title/Abstract] OR "obstipation*"[Title/Abstract] OR "fecal impaction"[MeSH Terms] OR (("feces"[MeSH
Terms] OR "feces"[Title/Abstract] OR "fecal"[Title/Abstract] OR "faecal"[Title/Abstract]) AND ("impaction"[Title/Abstract]
OR "retention"[Title/Abstract] OR "evacuation"[Title/Abstract]))#2"ultrasonography"[MeSH Terms] OR "ultrasonograph*"[Title/Abstract] OR "ultra sonograph*"[Title/Abstract] OR"doptone"[Title/Abstract] OR "echogram*"[Title/Abstract] OR "echograph*"[Title/Abstract] OR "echo graph*"[Title/
Abstract] OR "echoscop*"[Title/Abstract] OR "echosound*"[Title/Abstract] OR "echo sound*"[Title/Abstract] OR"echotomograph*"[Title/Abstract] OR "echo tomograph*"[Title/Abstract] OR "sonogram*"[Title/Abstract] OR"sonograph*"[Title/Abstract] OR "ultrasonic*"[Title/Abstract] OR "ultra sonic*"[Title/Abstract] OR "ultrasound*"[Title/
Abstract] OR "ultra sound*"[Title/Abstract] OR "acoustic"[Title/Abstract] OR "B-mode"[Title/Abstract] OR "grayscale*"[Title/Abstract] OR "b scan*"[Title/Abstract]#3#1 and #2#4"english"[Language] OR "japanese"[Language]#5#3 and #4

Embase#1'constipation'/exp OR 'constipation' OR constipat*:ti,ab OR coprostasis:ti,ab OR costiveness:ti,ab OR 'defecation'/exp OR'defecation' OR defecat*:ti,ab OR dyschezia:ti,ab OR 'hard stool*':ti,ab OR obstipation*:ti,ab OR 'feces impaction'/exp OR'feces impaction' OR ((feces OR fecal OR faecal) NEAR/3 (impaction OR retention OR evacuation)) OR defaecat*:ti,ab#2'echography'/exp OR 'echography' OR ultrasonograph*:ab,ti OR 'ultra sonograph*':ab,ti OR doptone:ab,ti OR
echogram*:ab,ti OR echograph*:ab,ti OR 'echo graph*':ab,ti OR echoscop*:ab,ti OR 'echo scop*':ab,ti OR
echosound*:ab,ti OR 'echo sound*':ab,ti OR echotomograph*:ab,ti OR 'echo tomograph*':ab,ti OR sonogram*:ab,ti OR
sonograph*:ab,ti OR ultrasonic*:ab,ti OR 'ultra sonic*':ab,ti OR ultrasound*:ab,ti OR 'ultra sound*':ab,ti OR acoustic:ab,tiOR b-mode:ab,ti OR 'b scan*':ab,ti OR 'gray scale*':ab,ti#3english:la OR japanese:la#4#1 AND #2 AND #3#5#4 AND ('Conference Abstract'/it OR 'Conference Paper'/it OR 'Editorial'/it OR 'Letter'/it OR 'Note'/it)#6#4 NOT #5#7#6 AND ([adolescent]/lim OR [child]/lim OR [embryo]/lim OR [fetus]/lim OR [infant]/lim OR [newborn]/lim OR[preschool]/lim OR [school]/lim)#8#6 NOT #7#9#8 AND ('animal tissue'/de OR 'human cell'/de OR 'human tissue'/de OR 'nonhuman'/de)#10#8 NOT #9#11#10 AND ('case control study'/de OR 'comparative effectiveness'/de OR 'controlled clinical trial'/de OR 'controlled study'/
de OR 'diagnostic test accuracy study'/de OR 'meta analysis topic'/de OR 'practice guideline'/de OR 'randomized controlled
trial'/de OR 'randomized controlled trial topic'/de OR 'systematic review'/de)― 96 ―

Ichushi-Web#1((ultrasound/TA) or (ultrasound endoscopy /TH) or (ultrasonography/TA) or (doptone/TA) or (echogram/TA) or(echograph/TA) or (echoscop/TA) or (echosound/TA) or (echotomograph/TA) or (sonogram/TA) or (sonograph/TA) or(ultrasonic/TA) or (ultrasound/TA))#2(constipation/TH) or (constipation/TA) or (defecation/TH) or (defecation/TA) or (fecal impaction/TH) or (fecal
impaction/TA) or (feces/TH) or (feces/TA) or (bowel movement/TA)#3#1 and #2#4(#3) and (PT=exclude case report)#5(#4) and (PT=explanation, diagram, conference proceeding)#6#4 not #5#7(#6) and (CK=animal)#8#6 not #7#9(#8) and (CK=fetus, neonate, infant(1-23 months),toddler(2-5 years old),pediatric (6-12 years old))#10#8 not #9― 97 ―

3. The conﬂict of interest statuses

Organizational members and roles
Name (Organization)
Guideline
development
steering
committee

Guideline
development
group

Economic COI

Academic COI

Junko Sugama (Fujita Health
University)

None

None

Miyuki Ishibashi (Chiba University)

None

None

Shingo Okada* (Kitamihara Clinic)

None

None

Hiromi Sanada (Ishikawa Prefectural
Nursing University)

None

None

Atsushi Nakajima* (Yohokama City
University)-Lecture fees: EA Pharma Co., Ltd., Astellas Pharma None
Inc., Mochida Pharma Co., Ltd., Mylan EPD,
Biofermin Pharma Co., Ltd. (2020-2021)-Research funding: EA Pharma Co., Ltd., Astellas
Pharma Inc., Mochida Pharma Co., Ltd., Mylan
EPD. (2020-2021)- Scholarship Donations (2,000,000 JPN or more):
EA Pharma Co., Ltd.

Takeo Nakayama* (Kyoto University) None

None

Kaoru Nishimura (Continence Japan
Co., Ltd.)

None

None

Junko Sugama (Fujita Health
University)

None

None

Nao Tamai (Yokohama City
University )-Endowed chairs (affiliations): From April 2019 toMarch 2022: Social cooperation course (Investor:
FUJIFILM Corporation)

None

Erika Ota (St. Luke's International
University)

None

None

Atsuo Kawamoto (Tokyo Medical
University Hospital)

None

None

Hiroe Koyanagi (Fujita Health
University)

None

None

Chiaki Sakakibara (Home-visit
Nursing Agency Yaya's House)

None

None

Mihoko Seki* (JCHO Tokyo Yamate
Medical Center)

None

None

Momoko Tsuda* (Hokkaido Cancer
Society)

None

None

Masaru Matsumoto (Ishikawa
Prefectural Nursing University)-Endowed chairs (affiliations): From April 2017 toAugust 2021: Social cooperation course (Investor:
FUJIFILM Corporation)

None

Noboru Misawa* (Yohokama City
University)

None

None

― 98 ―

Systematic
review teamMiku Aoki (University of Fukui)

None

None

Ayumi Amemiya (Chiba University)

None

None

Fumiko Ishimitsu (Aichi Prefectural
University)

None

None

Tomohiro Ishinuki (Sapporo Medical None
University)

None

Beniko Itokawa (Japanese Red Cross
Akita College of Nursing)

None

None

Tamae Urai (Toyama Prefectural
University)

None

None

Masashi Katogi (Kanagawa Universityof Human Services)

None

None

Aya Kitamura (The University ofTokyo)

None

None

Shimizu Mikiko (Fujita Health
University)

None

None

Chikoto Suzuki (Saiseikai Yokohamashi Tobu Hospital)

None

None

Nozomi Sonoda (Takarazuka
University)

None

None

Misako Dai (Ishikawa Prefectural
Nursing University)-Endowed chairs (affiliations): From April 2019 toMarch 2021: Social cooperation course (Investor:
Saraya Corporation)

None

Toshiaki Takahashi (The Universityof Tokyo)-Endowed chairs (affiliations): From April 2018 toNone
September 2020: Social cooperation course (Investor:
Molten corporation)

Rumi Tanaka (Kitasato University)

None

None

Taiki Teshima (Kansai Medical
University)

None

None

Ayano Nakai (Fujita Health
University)

None

None

Mayumi Hamada (Tokyo Jikei
University)

None

None

Yuka Miura (Fujita Health University) -Endowed chairs (affiliations): From April 2019 toMarch 2022: Social cooperation course (Investor:
FUJIFILM Corporation)

None

Yuko Mugita (The University ofTokyo)None

None

Tamami Mori (Tokyo Shinjuku
Medical Center Affiliated Nursing
School)

None

None

― 99 ―

Panelmembers

Junko Sugama (Fujita Health
University )

None

None

Nao Tamai (Yokohama City
University )-Endowed chairs (affiliations): From April 2017 toAugust 2021: Social cooperation course (Investor:
FUJIFILM Corporation)

None

Keiko Ishihama* (JCHO Hoshigaoka
Medical Center)

None

None

Erika Ota (St. Luke's International
University)

None

None

Miho Okabe* (Wound and skinhome care station)

None

None

Atsuo Kawamoto* (Tokyo Medical
University Hospital)

None

None

Yoshifumi Kido (Hamamatsu
University School of Medicine)

None

None

Takaomi Kessoku* (the International
University of Health and Welfare
Narita Hospital)-Research funding (2,000,000JPN or more): EA
Pharma Co., Ltd., Mochida Pharma Co., Ltd.

None

Hiroe Koyanagi (Fujita Health
University)

None

None

Chiaki Sakakibara (Home-visit
Nursing Agency Yaya's House)

None

None

Mihoko Seki* (JCHO Tokyo Yamate
Medical Center)

None

None

Momoko Tsuda* (Hokkaido Cancer
Society)

None

None

Masaru Matsumoto (Ishikawa
Prefectural Nursing University)-Endowed chairs (affiliations): From April 2017 toAugust 2021: Social cooperation course (Investor:
FUJIFILM Corporation)

None

Noboru Misawa* (Yohokama City Un Noneiversity)

None

Cooperating
memberKuniko Sato (St. Luke's International
University)

None

None

Secretariat

Masaru Matsumoto (Ishikawa
Prefectural Nursing University)-Endowed chairs (affiliations): From April 2017 toAugust 2021: Social cooperation course (Investor:
FUJIFILM Corporation)

None― 100 ―

External
evaluationcommittee

Eikichi Ihara (Kyushu University)-Lecture fees: Takeda Pharma Co., Ltd.
-Endowed chairs (affiliations): Ono Pharma Co.,
Ltd., Miyarisan Pharma Co., Ltd., Sanwa Kagaku
Kenkyusho Co., Ltd., Otsuka Pharmaceutical
Factory, Inc., FUJIFILM Medical Co., Ltd., Terumo
Corp., Fancl Corp., OHGA Pharmacy Co., Ltd.

None

Hiroyuki Imaeda (Saitama Medical
University Hospital)-Lecture fees (500,000 JPN or more): SHINDANTO CHIRYO SHA, Inc.

None

Toshiko Kaitani (Sapporo City
University)

None

None

Takashi Kawazoe (Carepro Inc.)-Employment/ Advisory role: Carepro, Inc.
representative director-Stock ownership: Carepro, Inc.

None

Takeya Yasushi (Osaka University)-Lecture fees: Daiichi Sankyo, Inc., Astellas Pharma
Inc.

None

Michio Maruyama (Tanashi Hospital)

None

None

Yu Maruyama (Saitama Prefectual
University)

None

None

Toshiki Mimura (Jichi Medical
University)

None

Related clinical guideline
preparation members: ViceChair, The Japan Society ofColoproctology― 101 ―