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Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
Sponsor: Skane University Hospital
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.
Official title: SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
212
Start Date
2024-09-01
Completion Date
2030-12-31
Last Updated
2025-05-21
Healthy Volunteers
No
Conditions
Interventions
selective approach defunctioning stoma
With randomisation to this experimental arm (selective approach), no defunctioning stoma is constructed.
Locations (1)
Skåne University Hospital
Malmo, Sweden