Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

Last updated: May 15, 2025
Sponsor: Skane University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Colon Cancer

Rectal Cancer

Treatment

selective approach defunctioning stoma

Clinical Study ID

NCT06214988
2023-0437-01
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with rectal cancer planned for a low anterior resection withanastomosis 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 asdetermined by the anaesthesiologist or the surgeon

  • Patients without clear radiological signs of distant disease before rectal cancersurgery (previous metastatic surgery is no exclusion criterion)

  • Anastomotic leak risk score of 0-1

  • Willingness to be randomised

Exclusion

Exclusion Criteria:

  • Insufficient command of Swedish, Norwegian, Danish or English to understandquestionnaires or consent

  • Emergency rectal resection (tumour resection due to large bowel obstruction,perforation, etc)

  • Pregnancy or breastfeeding Additional exclusion criteria for randomised part of thestudy

  • 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 thesurgeon in charge) Intraoperative exclusion criteria for randomised part of thestudy

->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 operatingsurgeon (e.g. ureterotomy, bowel or tumour perforation, major medical event -pulmonary embolism, cardiac arrhythmia) (Gawria, 2022)

  • TME with anastomosis ultimately not done

Study Design

Total Participants: 212
Treatment Group(s): 1
Primary Treatment: selective approach defunctioning stoma
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
December 31, 2030

Study 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 suggest that this comes at the price of worse bowel dysfunction, a higher rate of permanent stomas and kidney injury. We aim to study whether a selective strategy of defunctioning stoma use might lead to fewer adverse consequences, while still being safe for patients.

This is a multicentre international prospective trial including a non-blinded randomised clinical trial. All patients with a primary rectal cancer planned for low anterior resection with colorectal or coloanal anastomosis are eligible. Patients enter a prospective observational study, in which a randomised clinical trial is nested. Patients eligible for randomisation are aged below 80 years, have an American Society of Anesthesiologists' fitness grade I or II, have no unresected distant disease, and have a predicted lower risk of anastomotic leakage. Patients will be randomised 1:1 to either an experimental arm with no defunctioning stoma or to a control arm with a defunctioning stoma. The randomisation is computer-generated with a concealed sequence and stratified by participating hospital and radiotherapy use. The main outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). 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. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients.

This study has been approved by Ethical Review Authority in Sweden (2023-04347-01) and seeks permission in Norway and Danmark, respectively. The results will be disseminated through patient associations, popular science, the broader medical community, and conventional scientific channels.

Connect with a study center

  • Skåne University Hospital

    Malmö,
    Sweden

    Active - Recruiting

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