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NCT06214988Not yet recruiting

Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
Skane University HospitalClinicalTrials.govprocedure
Study focus
Disease/Condition
Rectal Cancer
Drug/Device/Intervention
selective approach defunctioning stoma
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Skane University Hospital
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2024
End date
Dec 31, 2030
Enrollment
212 participants
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
Malignant neoplasm of rectumCarcinoma in situ: RectumBenign neoplasm: RectumSecondary malignant neoplasm of large intestine and rectumCarcinoma in situ: Rectosigmoid junction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06214988
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.