A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery (PMCRBDSPS)

A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer; Bowel Dysfunction

• Study Type: Observational
• Enrollment (Anticipated): 460

Contacts and Locations

• Study Contact: Name: Fan Liu, M.D.; Phone Number: +86-188-1159-0087; Email: liufan_md@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Rectal cancer patients who accept sphincter-preserving surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
sphincter-preserving surgery; Patients meet the inclusion criteria will be enrolled into this observing group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of bowel dysfunction after sphincter-preserving surgery	one year
Risk factors of bowel dysfunction after sphincter-preserving surgery	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of each symptoms of bowel dysfunction		one year
Prognosis of bowel dysfunction after sphincter-preserving surgery		one year
Incidence of bowel dysfunction after sphincter-preserving surgery	comparing incidences between high and low anastomsis site	one year

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Guangdong Provincial Hospital of Traditional Chinese Medicine; Xiangya Hospital of Central South University; Beijing Friendship Hospital; The Affiliated Hospital of the Chinese Academy of Military Medical Sciences; Peking University Cancer Hospital & Institute; Peking University International Hospital; China-Japan Friendship Hospital; The First Hospital of Jilin University; Hebei Medical University Fourth Hospital; The First People's Hospital of Changzhou; Qilu Hospital of Shandong University (Qingdao); the first affiliated hospital of Jiamusi university
• Investigators: Study Chair: Yingjiang Ye, M.D./ PhD, Chinese Society of Colon and Rectal Surgeons

Publications and helpful links

General Publications

• 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. Erratum In: JMIR Mhealth Uhealth. 2021 Apr 10;9(4):e29325.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 2, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: rectal cancer; anterior resection syndrome; sphincter-preserving surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: BaS-1611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES