Status:
RECRUITING
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
Lead Sponsor:
Skane University Hospital
Collaborating Sponsors:
Umeå University
Lund University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pr...
Detailed Description
Systematic use of defunctioning stoma after low anterior resection for rectal cancer has been shown to reduce symptomatic anastomotic leakage and associated interventions. However, accumulating data s...
Eligibility Criteria
Inclusion
- 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
- Patients without clear radiological signs of distant disease before rectal cancer surgery (previous metastatic surgery is no exclusion criterion)
- Anastomotic leak risk score of 0-1
- Willingness to be randomised
Exclusion
- Insufficient command of Swedish, Norwegian, Danish or English to understand questionnaires or consent
- Emergency rectal resection (tumour resection due to large bowel obstruction, perforation, etc)
- Pregnancy or breastfeeding Additional exclusion criteria for randomised part of the study
- Previous pelvic irradiation (due to e.g. gynaecological or urological cancer)
- Preoperative tumour perforation or pelvic sepsis
- Beyond TME surgery and/or concurrent resection of other organ
- Concurrent corticosteroid treatment (prednisone-equivalent dosage ≥10 mg daily)
- Planned postoperative chemotherapy
- Smoking not completely ceased four weeks before surgery
- Excessive alcohol consumption with social and medical consequences (as judged by the surgeon in charge) Intraoperative exclusion criteria for randomised part of the study
- \>2 staple firings for rectal transection
- Intraoperative blood loss ≥250 ml for minimally invasive surgery
- Intraoperative blood loss ≥500 ml for open or converted surgery
- More than one intraabdominal anastomosis performed
- Incomplete doughnuts
- Air-leak test positive
- Any significant intraoperative adverse event at the discretion of the operating surgeon (e.g. ureterotomy, bowel or tumour perforation, major medical event - pulmonary embolism, cardiac arrhythmia) (Gawria, 2022)
- TME with anastomosis ultimately not done
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT06214988
Start Date
September 1 2024
End Date
December 31 2030
Last Update
May 21 2025
Active Locations (1)
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1
Skåne University Hospital
Malmo, Sweden