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

• Conditions: Rectal Cancer; Bowel Dysfunction

• Registration Number: NCT03009747
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-02
• Last Update Submitted: 2017-01-02
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of bowel dysfunction after sphincter-preserving surgery	one year
Risk factors of bowel dysfunction after sphincter-preserving surgery	one year

Secondary Outcome Measures

Name	Time	Method
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