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

Sponsor

Peking University People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03009747

Collaborator

The First People's Hospital of Changzhou (Other), Peking University Cancer Hospital & Institute (Other), Beijing Friendship Hospital (Other), Guangdong Provincial Hospital of Traditional Chinese Medicine (Other), Hebei Medical University Fourth Hospital (Other), the first affiliated hospital of Jiamusi university (Other), China-Japan Friendship Hospital (Other), The First Hospital of Jilin University (Other), The First Affiliated Hospital of Anhui Medical University (Other), The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other), Xiangya Hospital of Central South University (Other), Qilu Hospital of Shandong University (Qingdao) (Other), Peking University International Hospital (Other)

460

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Dysfunction Rectal Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

460 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
sphincter-preserving surgery Patients meet the inclusion criteria will be enrolled into this observing group

Outcome Measures

Primary Outcome Measures

Incidence of bowel dysfunction after sphincter-preserving surgery [one year]
Risk factors of bowel dysfunction after sphincter-preserving surgery [one year]

Secondary Outcome Measures

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 [one year]
comparing incidences between high and low anastomsis site

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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