Clinical trial NCT03009747: A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery
Official title: A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bowel Dysfunction
Rectal Cancer
Keywords: rectal cancer
anterior resection syndrome
sphincter-preserving surgery
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: The First People's Hospital of Changzhou
name: Peking University Cancer Hospital & Institute
name: Beijing Friendship Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Hebei Medical University Fourth Hospital
name: the first affiliated hospital of Jiamusi university
name: China-Japan Friendship Hospital
name: The First Hospital of Jilin University
name: The First Affiliated Hospital of Anhui Medical University
name: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
name: Xiangya Hospital of Central South University
name: Qilu Hospital of Shandong University (Qingdao)
name: Peking University International Hospital
First posted: 2017-01-04
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer patients who accept sphincter-preserving surgery

Brief summary: This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Adenocarcinoma confirmed by pathology
3. Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope.
4. The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).
5. The operation is estimated to be sphincter-preserving.
6. The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is ≤ 2.
7. The estimated life time is not less than one year.
8. The patient agree to sign the informed consent.

Exclusion Criteria:

1. The patient refuse to follow research plan.
2. Emergency case
3. Pregnant and lactating female patient
4. The patient did not accept radical resection.
5. The patient did not accept first stage resection and anastomosis.
6. The patient has experienced anal-rectal surgery.
7. The patient has experienced left colon surgery.
8. The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis.
9. The patient was diagnosed with cognitive or communicative obstacles.
10. The patient was diagnosed with serious repeated infection or other concomitance diseases.
11. The patient has participated other medical research which may affect his/her bowel function.

Primary outcomes:
measure: Incidence of bowel dysfunction after sphincter-preserving surgery
timeFrame: one year
measure: Risk factors of bowel dysfunction after sphincter-preserving surgery
timeFrame: one year
Secondary outcomes:
measure: Incidence of each symptoms of bowel dysfunction
timeFrame: one year
measure: Prognosis of bowel dysfunction after sphincter-preserving surgery
timeFrame: one year
measure: Incidence of bowel dysfunction after sphincter-preserving surgery
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Chinese Society of Colon and Rectal Surgeons
name: Yingjiang Ye, M.D./ PhD
role: STUDY_CHAIR
References:
citation: Liu F, Guo P, Su X, Cui M, Jiang J, Wang S, Yu Z, Zhou R, Ye Y. A Novel Remote Follow-Up Tool Based on an Instant Messaging/Social Media App for the Management of Patients With Low Anterior Resection Syndrome: Pilot Prospective Self-Control Study. JMIR Mhealth Uhealth. 2021 Mar 19;9(3):e22647. doi: 10.2196/22647.