Rectal Cancer Trial On Defunctioning Stoma

Rectal Cancer Trial on Defunctioning Stoma Study Group234 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

234

Conditions

Rectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Surgery, Linköping University Hospital

Linköping, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 30 days, one year and five years.

Secondary Outcomes

Reoperation within 30 days of initial surgery.

Time frame: 30 days

Data from ClinicalTrials.gov

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