Rectal Cancer Trial On Defunctioning Stoma

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT00636948
• Lead Sponsor: Rectal Cancer Trial on Defunctioning Stoma Study Group

Brief Summary

The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.

Detailed Description

The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.

Study Timeline

• Study Start: 1999-12
• Primary Completion: 2005-06
• Study First Submitted: 2008-02-11
• Status Verified: 2008-03
• Study First Submitted QC: 2008-03-10
• Last Update Submitted: 2008-03-10
• Study First Posted: 2008-03-17
• Last Update Posted: 2008-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• Absence of intraoperative adverse events according to the study protocol and the operating surgeon.

Exclusion Criteria

• Presence of intraoperative adverse events according to the study protocol and the operating surgeon.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma.	30 days, one year and five years.

Secondary Outcome Measures

Name	Time	Method
Reoperation within 30 days of initial surgery.	30 days

Trial Locations

Locations (1)

Department of Surgery, Linköping University Hospital; 🇸🇪 Linköping, Sweden