Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

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.

NCT Number	NCT06214988
Lead Sponsor	Skane University Hospital Collaborators: Umeå University, Lund University, Göteborg University, Ersta Hospital, Sweden, Copenhagen University Hospital at Herlev, Linkoeping University, Oslo University Hospital, Örebro University, Sweden
Conditions	Rectal Cancer
Enrollment	212 participants
Start Date	2024-09-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-21