NCT06214988

Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational trial with a nested randomized controlled trial is to investigate a selective approach of defunctioning stoma in low anterior resection in rectal cancer patients. The primary outcome is a hybrid so-called textbook outcome; stoma-free survival at two years without major LARS, reflecting a functionally appropriate outcome after low anterior resection for rectal cancer. Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery.

Detailed description

Systematic use of defunctioning stoma after low anterior resection for rectal cancer has been shown to reduce symptomatic anastomotic leakage and associated interventions. However, accumulating data suggest that this comes at the price of worse bowel dysfunction, a higher rate of permanent stomas and kidney injury. We aim to study whether a selective strategy of defunctioning stoma use might lead to fewer adverse consequences, while still being safe for patients. This is a multicentre international prospective trial including a non-blinded randomised clinical trial. All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible. Patients enter a prospective observational study, in which a randomised clinical trial is nested. Patients eligible for randomisation are aged below 80 years, have an American Society of Anesthesiologists' fitness grade I or II, have no unresected distant disease, and have a predicted lower risk of anastomotic leakage. Patients will be randomised 1:1 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma. The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use. The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS, and permanent stoma rate up to two years after index surgery. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients. This study has been approved by Ethical Review Authority in Sweden (2023-04347-01) and seeks permission in Norway and Danmark, respectively. The results will be disseminated through patient associations, popular science, the broader medical community, and conventional scientific channels.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	selective approach defunctioning stoma	With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2024-01-22
• Last updated: 2025-05-21

Locations

1 site across 1 country: Sweden