Rectal Cancer Trial On Defunctioning Stoma

Rectal Cancer Trial On Defunctioning Stoma

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.

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.