Selective use of stoma in rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational trial investigates a selective approach to using defunctioning stomas in patients undergoing low anterior resection for rectal cancer. It aims to determine if this selective strategy can reduce adverse outcomes such as bowel dysfunction and the need for permanent stomas while maintaining safety. The study includes a nested randomized controlled trial where eligible patients are assigned to either receive a defunctioning stoma or not, with outcomes measured over two years. Key outcomes include stoma-free survival and rates of complications like anastomotic leakage and quality of life.

Why it matters

Who can join: the full rules

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

Where it's running

• Skåne University Hospital
  Malmö, Sweden Recruiting

Study contacts

• Principal investigator: Pamela Buchwald, MD PhD — Skåne University Hospital, Lund University
• Study coordinator: Caroline Nilsson, RN
• Email: caroline.n.nilsson@skane.se
• Phone: 004640331000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.