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 i

Trial Details

NCT ID
NCT06214988
Phase
NA
Sponsor
Skane University Hospital
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • selective approach defunctioning stoma
Locations (sample)
  • Malmö, Sweden|55.60587,13.00073

Key Eligibility Criteria

  • Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach
  • Additional inclusion criteria for randomised part of the study:
  • Patients aged less than 80 years
  • Patients with American Society of Anesthetists' (ASA) fitness grade I or II as determined by the anaesthesiologist or the surgeon

For full eligibility, visit ClinicalTrials.gov.

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