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RECRUITING
NCT06214988
NA

Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

Sponsor: Skane University Hospital

View on ClinicalTrials.gov

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

PROCEDURE

selective approach defunctioning stoma

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

Locations (1)

Skåne University Hospital

Malmo, Sweden