Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

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.

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions2

Browse More Trials