Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer - Trial NCT06214988
Access comprehensive clinical trial information for NCT06214988 through Pure Global AI's free database. This phase not specified trial is sponsored by Skane University Hospital and is currently Not yet recruiting. The study focuses on Rectal Cancer. Target enrollment is 212 participants.
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Study Focus
Sponsor & Location
Skane University Hospital
Timeline & Enrollment
N/A
Sep 01, 2024
Dec 31, 2030
Primary Outcome
textbook outcome; stoma-free survival at two years without major LARS
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06214988
Non-Device Trial