Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkane University Hospital

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

212 Participants
are divided into 2 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