Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer

Recruiting now · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT06214988

Run by

Skane University Hospital

People needed

212

Starts

2024-09-01

Expected to finish

2030-12-31

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Skåne University Hospital — Malmö, Sweden (enrolling)

Full record on ClinicalTrials.gov

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