Actively Recruiting
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
Led by Skane University Hospital · Updated on 2025-05-21
212
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
Sponsors
S
Skane University Hospital
Lead Sponsor
U
Umeå University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with rectal cancer planned for low anterior resection with anastomosis by total mesorectal excision
- For the randomized part: patients younger than 80 years
- Fitness grade I or II by anesthesiologist or surgeon
- No clear radiological signs of distant disease before surgery
- Anastomotic leak risk score of 0-1
- Willingness to be randomized
You will not qualify if you...
- Insufficient understanding of Swedish, Norwegian, Danish, or English to complete questionnaires or consent
- Emergency rectal resection for obstruction or perforation
- Pregnancy or breastfeeding
- Previous pelvic irradiation
- Preoperative tumor perforation or pelvic sepsis
- Surgery beyond total mesorectal excision or concurrent organ resection
- Current corticosteroid treatment at prednisone-equivalent 10 mg daily or more
- Planned postoperative chemotherapy
- Smoking not fully stopped at least four weeks before surgery
- Excessive alcohol use with social or medical consequences
- More than two staple firings for rectal transection during surgery
- Excessive intraoperative blood loss (≥250 ml for minimally invasive, ≥500 ml for open or converted surgery)
- More than one intraabdominal anastomosis
- Incomplete doughnuts or positive air-leak test
- Significant intraoperative adverse events as judged by the surgeon
- Surgery without total mesorectal excision with anastomosis
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Trial Site Locations
Total: 1 location
1
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
Research Team
C
Caroline Nilsson, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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