About this trial
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.
Eligibility criteria
Qualifiers
Adult patients with rectal cancer planned for a low anterior resection with anastomosis by TME with any surgical approach
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- selective approach defunctioning stoma
Treatment groups
Sponsors and collaborators
Skane University Hospital
Lead sponsor
Umeå University
Collaborator
Lund University
Collaborator
Göteborg University
Collaborator
Ersta Hospital, Sweden
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Linkoeping University
Collaborator
Oslo University Hospital
Collaborator
Örebro University, Sweden
Collaborator