Conditions: Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 97
Healthy volunteers: yes

Brief summary:
Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) gynecologic surgery and is a major source of anxiety and discomfort. The average time to first bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication use, chronic nonsteroidal anti-inflammatory drugs (NSAID) use and anatomic manipulation.

There are no established regimens to manage postoperative constipation after minimally invasive gynecologic surgery. Two studies evaluating the implementation of postoperative bowel regimen with polyethylene glycol (PEG) and with Senna and Docusate found no significant impact on postoperative bowel function. There have been no studies looking at the effect of preoperative bowel regimens on postoperative bowel function.

The purpose of this study is to evaluate postoperative bowel function after minimally invasive hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily.

Detailed description:
Following enrollment subjects will be randomized into the intervention/treatment arm and control arm. All subjects will be asked to complete a baseline demographic form and three questionnaires (Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC- QOL), Wexner Constipation score). Additional demographic information will be obtained from chart review. This information will include past medical history, use of constipating medications, use of daily pain medications, chronic pain history, use of daily fiber supplementation.

Subjects in the intervention arm will be given 10-day supply of Miralax and instructed on its use. They will take this medication for the 10 days prior to surgery. Subjects in the control arm will continue with standard care prior to surgery.

Post operatively, all subjects will complete a diary for 7 days. In this diary they will record details about their bowel movements (time of movement, discomfort, texture of stool). They will also report average daily pain levels ( with a visual analog scale), daily pain medication use (time, medication, total number of pills).

At the end of the 7th day all subjects will complete the same PAC questionnaires as they did pre-operatively.

Arms:
arm 1: Participants will receive 10 doses, 17g each, of polyethylene glycol 3350. They will be instructed to take 1 dose/packet each day for 10 days leading up to their surgery. arm 2: Participants will not be given any laxatives.

Interventions: intervention 1: Polyethylene Glycol 3350
Intervention descriptions: intervention 1: Participants will take 1 17g pack per day for 10 days preceding surgery.

Protocol document:
Prot_SAP_001.pdf: 
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RESEARCH STUDY PROTOCOL 
 
 
Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial 
NCT04263896 January 24, 2025


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Title: Bowel Function After Minimally Invasive Hysterectomy: A Randomized Controlled Trial 
 
Abbreviated Title: Bowel Function/PEG study 
 
 
Principal Investigator(s):  
Dianne H. Glass MD PhD 
Assistant Professor 
Urogynecology and Reconstructive Pelvic Surgery 
Department of Obstetrics & Gynecology 
University of Chicago Medicine & Biological Sciences 
5841 S. Maryland Ave MC 2050 
Chicago, IL 60637 
Email: dianneglass@bsu.uchicago.edu 
 
Obianuju Sandra Madueke-Laveaux, MD MPH 
Assistant Professor 
Section of Minimally Invasive Gynecologic Surgery 
Department of Obstetrics & Gynecology 
University of Chicago Medicine & Biological Sciences 
5841 S. Maryland Ave MC 2050 
Chicago, IL 60637 
Email: slaveaux@bsd.uchicago.edu  
 
 
Co-Investigators: 
 
Shilpa Iyer MD 
Assistant Professor, Urogynecology 
University of Chicago 
 
Josephine Kim MD 
Assistant Professor, Gynecologic Oncology 
University of Chicago 


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Table of Contents 
ABSTRACT ................................................................................................................................. 4 
1.0 STUDY PURPOSE AND RATIONALE .................................................................................. 4 
2.0 STUDY DESIGN AND STATISTICAL PROCEDURES .......................................................... 5 
2.1 
Overall design ................................................................................................................ 5 
Type of study: A randomized controlled trial .............................................................................. 5 
Randomization: Block randomization by surgical subspecialty-  minimally invasive gynecologic 
surgery, urogynecology, gynecologic oncology ......................................................................... 5 
Single vs. multi-center: Single center ........................................................................................ 5 
2.2 
Study objectives ............................................................................................................. 5 
2.3 
Aims & Hypotheses ........................................................................................................ 5 
2.4 
Data Management and Analysis ..................................................................................... 6 
2.5 
Graphical schema of study ............................................................................................. 7 
4.0 STUDY DRUGS ..................................................................................................................... 8 
5.0 STUDY INSTRUMENTS: Questionnaires (See Appendix) .................................................. 8 
6.0 STUDY SUBJECTS ............................................................................................................... 8 
6.1 
Inclusion criteria: ............................................................................................................ 8 
6.2 
Exclusion criteria: ........................................................................................................... 8 
7.0 RECRUITMENT ..................................................................................................................... 9 
8.0 INFORMED CONSENT PROCESS........................................................................................ 9 
9.0 CONFIDENTIALITY OF STUDY DATA................................................................................ 11 
10.0 PRIVACY PROTECTIONS ................................................................................................. 11 
11.0 POTENTIAL RISKS ........................................................................................................... 11 
12.0 DATA AND SAFETY MONITORING .................................................................................. 11 
13.0 POTENTIAL BENEFITS .................................................................................................... 11 
14.0 ALTERNATIVES ................................................................................................................ 11 
15.0 RESEARCH AT EXTERNAL SITES .................................................................................. 12 
16.0 UNIVERSITYOF CHICAGO AS LEAD INSTITUTION ........................................................ 13 
Proposed Timeline ................................................................................................................... 13 
References ............................................................................................................................... 13 
 


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ABSTRACT 
Postoperative constipation affects up to a third of women undergoing minimally invasive (MIS) 
gynecologic surgery and is a major source of anxiety and discomfort. The average time to first 
bowel movement after gynecologic surgery is about 2 to 4 days and some factors responsible 
for this include anesthesia inhibitory effect on gastrointestinal motility, opioid pain medication 
use, chronic NSAID use and anatomic manipulation[1]. 
 
There are no established regimens to manage postoperative constipation after minimally 
invasive gynecologic surgery. A few post-operative regimens have been investigated with mixed 
results. One such study evaluating the implementation of postoperative bowel regimen with 
polyethylene glycol (PEG) vs. Docusate found no significant impact on postoperative bowel 
function while another found improved constipation with use of Docusate and Senna vs. 
placebo. [1, 2]. There have been no studies looking at the effect of preoperative bowel regimens 
on postoperative bowel function. 
 
The purpose of this study is to evaluate postoperative bowel function after minimally invasive 
hysterectomy in women receiving a preoperative 10-day bowel regimen of PEG daily. 
 
 
 
 
1.0 STUDY PURPOSE AND RATIONALE 
 
Hysterectomy is one of the most commonly performed surgeries in the United States. Many of the 
underlying conditions prompting hysterectomy such as uterine fibroids, pelvic organ prolapse, 
endometriosis and cancer contribute to baseline constipation.  Nineteen percent of hysterectomy 
patients and 27% of patients undergoing prolapse on urinary incontinence surgery have baseline 
constipation [3]. Additionally, patients undergoing pelvic surgery are at increased risk of 
constipation post-operatively due to anesthesia, bowel manipulation, inactivity and narcotic use 
[4-6]. A study reported that 13.7% of urogynecology patients called the office post operatively 
with concerns related to constipation[7]. A similar study looking at post-operative complaints in a 
general gynecology population found that 34% of patients reported constipation symptoms after 
discharge [8]. In addition to the bloating and discomfort caused by constipation, avoidance of 
straining with defecation may help prevent the development or recurrence of pelvic organ 
prolapse [9, 10]. Decreasing abdominal straining could also help prevent vaginal cuff dehiscence 
[11, 12] 
 
Postoperative docusate is commonly used after gynecologic surgery to prevent constipation, 
though little evidence exists to support this practice. Several postoperative regimens have been 
investigated but no clearly superior regimen has been identified. In urogynecology patients, 
docusate plus Senna was found to improve constipation and time to first bowel movement when 
compared with placebo [13].  However, Polyethylene glycol vs. Docusate did not show 
improvement in constipation symptoms or time to first bowel movement [14, 15].  In the 
Orthopedic literature, Lubiprostone was found to be equivalent to Senna [16].   
 
Given the high rate of baseline constipation and postoperative constipation in patients undergoing 
hysterectomy, and the unsatisfactory results with postoperative bowel regimens, we hypothesize 
that improving baseline constipation may help improve postoperative patient outcomes. For 
patients undergoing cardiac surgery, preoperative constipation was found to significantly predict 
post-operative constipation rates [17].  
 
Polyethylene glycol is an osmotic laxative that has been shown to be safe, effective and well 
tolerated for the treatment of both acute and chronic constipation [18]. It is readily available over 
the counter and has been shown to be safe for long-term use. The goal of this study is to assess 
the effect of preoperative administration of Polyethylene glycol on postoperative constipation 
symptoms and constipation related quality of life.   


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2.0 STUDY DESIGN AND STATISTICAL PROCEDURES 
2.1 Overall design 
  Type of study: A randomized controlled trial    
 
  Randomization: Block randomization by surgical subspecialty- division of minimally invasive 
gynecologic surgery, division of urogynecology, division of gynecologic oncology      
 
  Single vs. multi-center: Single center 
 
2.2 Study objectives 
2.2.1 Primary objective: To compare postoperative constipation as measured using 
PAC-QOL & PAC-SYM questionnaires in women receiving a 10-day preoperative bowel 
regimen versus those receiving standard preoperative care (no intervention) 
 
2.2.2 Secondary objectives: 
a) To compare postoperative abdominopelvic pain as measured on a VAS pain scale 
in women receiving a 10-day preoperative bowel regimen versus those receiving standard 
preoperative care (no intervention) 
b) To compare postoperative narcotic use in women receiving a 10-day preoperative 
bowel regimen versus those receiving standard preoperative care (no intervention) 
 
 
2.3 Aims & Hypotheses 
 
2.3a Specific Aim 1 
To determine if there is a difference in postoperative constipation between women receiving a 
10-day preoperative bowel regimen and those receiving standard preoperative care (no intervention) 
 
2.3a.1 Hypothesis 1 
Postoperative constipation is decreased in women receiving a 10-day preoperative bowel 
regimen versus those receiving standard preoperative care (no intervention) 
 
 
2.3b Specific Aim 2 
To determine if postoperative pain as measured on a VAS pain scale differs between women 
receiving a 10-day preoperative bowel regimen and those receiving standard preoperative care (no 
intervention) 
 
2.3b.1 Hypothesis 2 
Postoperative pain is improved in women receiving a 10-day preoperative bowel regimen 
versus those receiving standard preoperative care (no intervention) 
 
2.3c Specific Aim 3 
To determine if postoperative narcotic use differs between women receiving a 10-day 
preoperative bowel regimen and those receiving standard preoperative care (no intervention) 
 
2.3c.1 Hypothesis 3 
Postoperative narcotic use is decreased in women receiving a 10-day preoperative bowel 
regimen versus those receiving standard preoperative care (no intervention) 


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2.4 Data Management and Analysis 
In this study, the primary objective is to analyze the effect of 10-day preoperative bowel regimen 
on postoperative constipation as measured on PAC-QOL and PAC-SYM validated questionnaire 
 
Justification of sample size: For the PAC-SYS questionnaire the minimal important difference in 
the score is estimated to be 0.5 [19, 20]. Using the PAC-SYS score data from Edenfield et al [15] 
and Marciniak et. al [16]. We estimate that in order to detect a score difference of 0.5 on the PAC-
SYS score with 80% power and a two-sided alpha of 0.05 that we would require 78 subjects evenly 
divided into two groups. Assuming that there is a 20% drop out rate we plan to enroll 98 subjects for 
the main part of the study.  
 
We would like to do a small piolet of 3 patients to confirm that we are able to smoothly conduct the 
study. These 3 will be excluded from the final analysis. 
 
A total of 101 subjects will be enrolled. 
 
General Analyses 
 
Continuous variables will be summarized using means, standard deviations, medians, and 
ranges. If normally distributed, they will be analyzed using parametric tests such as T-test and 
analysis of variance. To find associations between continuous variables and to control by 
relevant covariates we will use multiple regressions. If the normality assumption is violated we 
will use non-parametric tests such as Mann-Whitney or Kruskal-Wallis. 
 
Categorical variables will be summarized with frequencies and percentages and analyzed 
with logistic regression or categorical response models. 95% confidence intervals will be 
provided for descriptive statistics, as warranted. Subject characteristics are assumed to be 
comparable at the start of the study (randomization design) and so no formal statistical group 
comparisons will be conducted on the subject characteristics. 
 
An overall alpha-level of 0.05 will be used as a cut-point for statistical significance and all 
statistical tests will be two-sided. All data will be analyzed by the University of Chicago Medicine 
Biostatistics team. 
 
 
 
 


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2.5 Graphical schema of study 
 
 
 
 
 
 
  
  
  
  
 
 
 
 
 
 
 
 
Control group 
No preoperative 
bowel regimen 
Intervention Group 
10-day preoperative 
bowel regimen 
Preoperative Randomization 
 
Preoperative data  
Basic demographics 
Use of constipation medications 
Use of daily pain medications 
Chronic pain history 
Use of daily fiber supplementation 
Baseline VAS pain scale (general & 
abdominopelvic pain) 
PAC-SYM questionnaire 
PAC- QOL questionnaire 
Wexner Constipation score 
Perioperative data 
Procedure name 
Operative time 
Complications 
Anesthesia type 
Length of Hospital stay 
Postoperative data 
Bowel diary (record BMs) 
Pain medication use 
Daily VAS pain scale 
PAC-SYM questionnaire 
PAC- QOL questionnaire 
Wexner Constipation score 


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3.0 STUDY PROCEDURES 
- 
For the piolet first 3 subjects they will be assigned to the treatment arm. For the 
remaining 98 subjects, after informed consent is obtained subjects will be randomized via 
sealed, opaque envelopes containing a sub-specialty block scheme to one of the two 
groups: 
o Control Group: Standard preoperative care (no preoperative bowel regimen) 
o Intervention Group: Preoperative bowel regimen (PEG 3350) 
 
- 
Subjects in the intervention group will be given the PEG 3350 (10-day supply) to use for the 10 
days prior to surgery. 
- 
Preoperative data will be obtained from all subjects: basic demographics, use of constipation 
medications, use of daily pain medications, chronic pain history, use of daily fiber 
supplementation, baseline VAS pain scale (general & abdominopelvic pain). 
- 
Preoperatively, all subjects will be requested to complete the following questionnaires: Wexner 
Constipation Score Questionnaire, validated PAC-SYM questionnaire, and PAC- QOL 
questionnaire 
- 
Perioperative data obtained will include procedure name, operative time, complications, 
anesthesia type, length of Hospital stay 
- 
Post operatively, all subjects will be requested to complete a bowel diary (record BMs), record 
pain medication use, report daily VAS pain scale, complete PAC-SYM questionnaire, PAC- 
QOL questionnaire and Wexner Constipation Score Questionnaire 
 
4.0 STUDY DRUGS  
MiraLAX, Polyethylene Glycol 3350 is an FDA approved over-the-counter osmotic laxative. It 
works by attracting water in the colon to ease, hydrate and soften stool. MiraLAX relieves 
constipation without gas, bloating, cramping or sudden urgency. In multiple clinical trials, MiraLAX 
has been proven to result in a BM within 24 to 72 hours. MiraLAX is formulated as a powder. 1 
packet of powder (17g) is stirred and dissolved in 4 to 8 oz. beverage; to be used daily for at least 
7 days.  
 
5.0 STUDY INSTRUMENTS: Questionnaires (See Appendix) 
6.0 STUDY SUBJECTS 
- 
Any woman ≥ 18 years of age undergoing a a minimally invasive hysterectomy 
(Laparoscopic, robotic, transvaginal)  
 
6.1 Inclusion criteria: 
- 
Any woman ≥ 18 years of age undergoing a minimally invasive hysterectomy (Laparoscopic, 
robotic, transvaginal)  
- 
Able to understand the consenting process and willing to participate in study 
 
6.2 Exclusion criteria: 
- 
Planned laparotomy 
- 
Emergent surgery 
- 
Regular preoperative use of PEG 3350, laxatives, enemas or suppositories 
- 
Planned bowel surgery 
- 
Presence of colostomy 
- 
Inability to consent 
- 
Medical problems as follows:  
o CKD (Cr: > 1.2 mg/dL) 
o IDDM 
o Cardiac disease 


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o Gastric ulcers 
o Difficulty swallowing or esophageal stricture 
o Persistent nausea or vomiting 
o Signs or symptoms  of a small bowel obstruction 
 
7.0 RECRUITMENT 
Benign gynecology, urogynecology or gynecologic oncology surgeons who perform minimally 
invasive hysterectomy will be asked for their permission to consider their patients for the study. 
 
A member of the research team will search the University of Chicago operating room schedules of 
the participating providers to identify potential study participants scheduled to undergo a minimally 
invasive hysterectomy. Data from the medical record system will be used to evaluate inclusion criteria.  
 
Once a subject has been identified, the research team will contact the operating surgeon via encrypted 
email for permission to contact the specific potential subject for study participation.  
 
A member of the research team will contact the potential subject offer them participation in the 
study and confirm participation criteria. Once a patient is identified as a potential study 
participant, the informed consent process will be completed as detailed in the ‘Informed 
Consent Process’ section. 
 
Please see informed consent section for further discussion of why in person recruitment and 
consent is not planned.  
 
8.0 INFORMED CONSENT PROCESS 
After a member of the research staff determines eligibility of study participants, the informed 
consent process will be completed in three possible ways as listed/explained below by the PI or 
research staff (Co-investigator or other delegated study staff): 
 
Option 1: (in person consent) 
- 
Subject will be offered an in person visit with a member of the research staff.  
- 
During this visit, the informed consent and HIPAA form will be explained and all questions 
answered 
- 
The informed consent and HIPAA form will be signed by the patient and a copy given to 
them for their personal records 
- 
The original ‘wet-ink’ signed consent and HIPAA form will be stored in a locked cabinet in 
the research coordinator’s office.  
- 
After consent, patient will be randomized and preoperative medication will be provided 
based on randomization group 
- 
All preoperative data as previously outlined will be obtained 
 
Option 2: (phone discussion with paper consent form) 
- 
The Subject will be offered a phone discussion. Prior to this phone discussion a copy of 
the consent form will be mailed to the subject. Receipt of consent will be verified before 
the phone consenting process begins. 
- 
During this conversation the informed consent and HIPAA form will be explained and all 
questions answered 
- 
Two copies of the consent and a stamped, addressed envelope will be mailed to the 
patient to sign and return the consent form. 
- 
After receipt of the consent the patient will be randomized and the subject will be 
randomized and the study medications and/or materials will be mailed to the subject.  
 
Option 3: (phone discussion with electronic consent form) 


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- 
The Subject will be offered a phone discussion. Prior to this phone discussion an email 
with a link / instructions for accessing REDCap will be sent to the subject. They will be 
instructed to access the electronic form in order to review it during the consenting 
process. 
- 
During this conversation the informed consent and HIPAA form will be explained and all 
questions answered 
- 
The patient will sign the electronic consent form accessed through REDCap.  
- 
Once the consent for is completed electronically the form will be printed and kept in a 
locked filling cabinet for our records.  
- 
The subject will be randomized and a copy of the signed consent form and the study 
medications and/or materials will be mailed to the subject.  
 
For all options, participants will have access to the consent form prior to and during the 
consenting process. In addition, when participation is offered to the patient, the informed 
consent and HIPAA form will be explained in detail along with the study design, procedures, 
inclusion/exclusion criteria, risks and benefits, and study requirement. It will be emphasized 
that participation is completely voluntary and that she may revoke her participation at any time. 
There will be no further documentation of the informed consent process. 
 
We recognize that in person consents are preferable. The above recruiting and consent process is 
being proposed for the following reasons:  
 
1) 
Patients undergoing minimally invasive hysterectomy will often have only one visit with 
the surgeon prior to surgery. During this visit a full history and physical is taken and 
surgical consent is performed. Attempting to perform study consent at this visit is not 
optimal for the following reasons 
a. It is likely that potential subjects will not be offered enrollment in the study because 
of time constraints.  
b. Consenting for this study on in addition to consent for surgery could be 
overwhelming for subjects and limit their ability to give a truly informed consent. A 
phone conversation at a later time would allow for the patient to have more time with 
the research staff and less to digest in one sitting. 
 
2) 
Hysterectomy patients often have preoperative visits that are several months before 
their surgery.  We would like consent patients for this study closer to the time they will 
be participating in the study. 
 
3) 
Gynecology sees outpatients at DCAM as well as a number of UCM facilities around 
southland Chicago. The off campus patients have a different socioeconomic and racial 
makeup and thus, should be included. Without phone recruiting and phone consent 
options off campus locations will have very limited participation for the following reasons 
a. Unless the treating provider is part of the research team, research staff is not 
available at off campus locations. 
b. Many of these patients live far from campus and will not be willing/able to come in 
for a dedicated study visit with our research staff. This would disproportionately 
impact patients who do not drive because of age or socioeconomic status.  
 
We feel that offering consent at a time separate from surgical consent is most respectful of our 
subjects and will allow for true informed consent. Offering a telephone option for consent will 
minimize the burden placed on subjects and be most inclusive. In person consent will also be 
offered to patients who prefer this.  
 
We additionally feel that offering an electronic consent will limit the burden placed on patients. It 
will limit the number of things that they need to receive in the mail and mail back to us.  
 
 


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9.0 CONFIDENTIALITY OF STUDY DATA 
To ensure confidentiality of medical information, each patient will be assigned a unique identifier 
in the database that can be linked to the medical record number. The database will be 
password-protected, encrypted and stored on a secure server accessible only from computers 
in the OBGYN department. Subject demographics and date will be entered into REDCap 
(system 4283). REDCap is a mature and secure web application for building and managing 
online surveys and databases. It allows data to be exported to Excel and SPSS. 
 
REDCap has the capacity for allowing patients to securely link to questionnaires and consent 
forms. The electronic consent form will be accessed via an email link. Our team has consulted 
with Julissa Acevedo who is in charge of REDCap for CRI. She agrees that REDCap is HIPPA 
compliant and data is encrypted during transmission, allowing for data collection out-of-
network, off-campus, remotely, etc. Patients are able to sign the consent for with the use of a 
mouse or a touch screen.  
 
10.0 PRIVACY PROTECTIONS 
The Principal Investigator and study staff will assure that the subject’s privacy will be strictly 
maintained and that their identities are protected from unauthorized parties. This will be 
accomplished by securing all study documents and subject information. These files will be 
accessible to study staff only and maintained in a secure study office. The study staff will assign 
a code (numbers and/or letters) to the subject for data analysis. Documents that contain 
identifiers will be kept in a locked research office and/or stored within computers with password 
protection and encryption. We will safeguard patients’ expectation that the information they 
offer will be held in confidence. We will protect each participant’s information as prescribed by 
the University and Hospital police and relevant Federal law. 
 
11.0 POTENTIAL RISKS 
There is minimal additional risk to the subjects in the intervention group. Miralax is an FDA 
approved medication for treatment and prevention of constipation. This medication has mild side 
effects, which may include loose watery or frequent stools. The patients’ privacy will be protected 
with the highest level of security however, potential for breaches in security must always be 
considered. 
 
12.0 DATA AND SAFETY MONITORING 
Study documents and subject information will be collected in files designed specifically for the 
study. These files will be accessible to study staff only and maintained in a locked and secure 
research study office. Electronic data will be stored in a mature and secure web application for 
building and managing online surveys and databases.  To ensure confidentiality of medical 
information, each patient will be assigned a unique identifier in the database that could be linked 
to the medical record number. The database will be password-protected, encrypted and stored on 
a secure server accessible only from computers in the OBGYN Division. For data analysis, all 
stored data will be exported to Excel and SPSS. 
 
13.0 POTENTIAL BENEFITS 
Patients in the intervention arm may experience improvement in postoperative constipation. 
There are otherwise no additional potential benefits to participants of this study.  
 
14.0 ALTERNATIVES 
The alternative to this study is not to participate 
 


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15.0 RESEARCH AT EXTERNAL SITES 
Not Applicable 


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16.0 UNIVERSITYOF CHICAGO AS LEAD INSTITUTION 
This is a single center study, with recruitment from University of Chicago Medical Center and a 
few satellite sites: Locations: The study patients will be recruited from outpatient settings of 
University of Chicago Medical Center: 
University of Chicago DCAM - 5758 S. Maryland Ave  Chicago, IL 60637 
University of Chicago South Loop - 1101 S. Canal St. Suites 201 & 202 Chicago, IL 60607 
University of Chicago Orland Park - 14290 S. La Grange Rd. Orland Park, IL 60462 
University of Chicago Harvey: 71 W. 156th St. Harvey, IL 60426 
University of Chicago Schererville: 222 Indianapolis Blvd. Schererville, IN 46375 
University of Chicago Streeterville : 680 N. Lake Shore Dr.Suite 117, Chicago, IL 60611 
University of Chicago Flossmoor: 19550 Governors Hwy. Flossmoor, IL 60422 
 
 
Proposed Timeline 
Overall timelines: (1.5) 
Date of initiation of study: 5/1/2019 
Date of study enrollment completion: 11/1/2020 
Follow up of last patient: 11/10/2020 
Date of completion of analysis and submission of publication: 2/1/2021 
 
 
References 
 
1. 
Patel, M., et al., The use of senna with docusate for postoperative constipation after pelvic 
reconstructive surgery: a randomized, double-blind, placebo-controlled trial. American 
Journal of Obstetrics and Gynecology, 2010. 202(5): p. 479.e1-479.e5. 
2. 
Edenfield, A.L., et al., Polyethylene Glycol 3350 and Docusate Sodium Compared With 
Docusate Sodium Alone After Urogynecologic Surgery: A Randomized Controlled Trial. 
Obstetrics & Gynecology, 2016. 128(3): p. 543-549. 
3. 
Clarke, A., et al., Indications for and outcome of total abdominal hysterectomy for benign 
disease: a prospective cohort study. Br J Obstet Gynaecol, 1995. 102(8): p. 611-20. 
4. 
Mythen, M.G., Postoperative gastrointestinal tract dysfunction: an overview of causes and 
management strategies. Cleve Clin J Med, 2009. 76 Suppl 4: p. S66-71. 
5. 
Pappagallo, M., Incidence, prevalence, and management of opioid bowel dysfunction. Am J 
Surg, 2001. 182(5A Suppl): p. 11s-18s. 
6. 
Corman, M.L., Management of postoperative constipation in anorectal surgery. Dis Colon 
Rectum, 1979. 22(3): p. 149-51. 
7. 
Iwanoff, C., M. Giannopoulos, and C. Salamon, Follow-up postoperative calls to reduce 
common postoperative complaints among urogynecology patients. Int Urogynecol J, 2018. 
8. 
Caljouw, M.A. and M.E. Hogendorf-Burgers, GYNOTEL: telephone advice to 
gynaecological surgical patients after discharge. J Clin Nurs, 2010. 19(23-24): p. 3301-6. 
9. 
Spence-Jones, C., et al., Bowel dysfunction: a pathogenic factor in uterovaginal prolapse 
and urinary stress incontinence. Br J Obstet Gynaecol, 1994. 101(2): p. 147-52. 
10. 
Arya, L.A., et al., Pelvic organ prolapse, constipation, and dietary fiber intake in women: a 
case-control study. Am J Obstet Gynecol, 2005. 192(5): p. 1687-91. 
11. 
Ramirez, P.T. and D.P. Klemer, Vaginal evisceration after hysterectomy: a literature review. 
Obstet Gynecol Surv, 2002. 57(7): p. 462-7. 
12. 
Hur, H.C., et al., Vaginal cuff dehiscence and evisceration: a review of the literature. Curr 
Opin Obstet Gynecol, 2016. 28(4): p. 297-303. 
13. 
Patel, M., et al., The use of senna with docusate for postoperative constipation after pelvic 
reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet 
Gynecol, 2010. 202(5): p. 479.e1-5. 


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14. 
McNanley, A., et al., Bowel function after minimally invasive urogynecologic surgery: a 
prospective randomized controlled trial. Female Pelvic Med Reconstr Surg, 2012. 18(2): p. 
82-5. 
15. 
Edenfield, A.L., et al., Polyethylene Glycol 3350 and Docusate Sodium Compared With 
Docusate Sodium Alone After Urogynecologic Surgery: A Randomized Controlled Trial. 
Obstet Gynecol, 2016. 128(3): p. 543-9. 
16. 
Marciniak, C.M., et al., Lubiprostone vs Senna in postoperative orthopedic surgery patients 
with opioid-induced constipation: a double-blind, active-comparator trial. World J 
Gastroenterol, 2014. 20(43): p. 16323-33. 
17. 
Iyigun, E., et al., Impact of preoperative defecation pattern on postoperative constipation for 
patients undergoing cardiac surgery. J Clin Nurs, 2017. 26(3-4): p. 495-501. 
18. 
Dipalma, J.A., et al., A randomized, multicenter, placebo-controlled trial of polyethylene 
glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol, 2007. 
102(7): p. 1436-41. 
19. 
Yiannakou, Y., et al., The PAC-SYM questionnaire for chronic constipation: defining the 
minimal important difference. Aliment Pharmacol Ther, 2017. 46(11-12): p. 1103-1111. 
20. 
Frank, L., et al., Psychometric validation of a constipation symptom assessment 
questionnaire. Scand J Gastroenterol, 1999. 34(9): p. 870-7. 


Postoperative constipation/PEG study protocol 
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Postoperative constipation/PEG study protocol 
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Postoperative constipation/PEG study protocol 
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