Selective defunctioning stoma approach in low anterior resection for rectal cancer (SELSA): a prospective study and a nested randomised clinical trial

Accumulating data suggest that systematic use of defunctioning stomas in low anterior resection for rectal cancer aiming to reduce symptomatic anastomotic leakage come at the price of long-term worse bowel dysfunction, high rate of permanent stomas, and kidney injury. Four out of five patients do not develop anastomotic leakage.

We aim to study whether a selective approach to defunctioning stoma may lead to better long-term outcomes while still being safe for patients.

In this Nordic multicentre study, all patients with a primary rectal cancer planned for low anterior resection are eligible.

Patients enter a prospective observational study including a translational substudy, in which a randomized clinical trial is nested for low-risk patients. Patients will be randomized 1:1 to either no stoma (experimental arm) or defunctioning stoma (control arm).

The primary outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome.

Secondary outcomes include anastomotic leakage, postoperative mortality, stoma-related morbidity and quality of life measures.

To demonstrate superiority (90% power, 25% attrition) 212 patients will be randomized and 500 patients included in the observational study during 3-years (first 100 patients feasibility trial).

This project will close several knowledge gaps regarding defunctioning stomas and anastomotic leakage in rectal cancer patients.