Rectal Cancer Trial On Defunctioning Stoma (RECTODES)

Rectal Cancer Trial on Defunctioning Stoma Study Group

Status: Completed

Conditions: Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00636948

Dnr 99039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.