Selective Use of Temporary Stoma After Low Rectal Cancer Surgery
Tests a selective approach to temporary stoma in adults having low rectal cancer surgery.
Plain-language title generated from the registry record
Registry title: Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
Key facts
- Where
- Malmö, SwedenSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rectal cancer who are planned for a low anterior resection with an anastomosis (a surgical join of the bowel). It studies when a temporary protective stoma is needed.
- Age
- 18 years or older. The randomised part is for people younger than 80 years.
- Sex
- All sexes can join.
- Disease stage
- Rectal cancer planned for low anterior resection with anastomosis by TME. For the randomised part: no clear signs of distant disease on scans before surgery (earlier surgery for metastases is allowed).
- Earlier treatment
- For the randomised part: no earlier radiation to the pelvis, no corticosteroid treatment at prednisone-equivalent 10 mg or more daily, and no planned chemotherapy after surgery.
- Biomarker or test result
- For the randomised part: an anastomotic leak risk score of 0-1.
Main reasons for not taking part
- Not enough command of Swedish, Norwegian, Danish or English to understand questionnaires or consent
- Emergency rectal resection, for example due to large bowel obstruction or perforation
- Pregnancy or breastfeeding
- Randomised part: ASA fitness grade above II, or smoking not completely stopped four weeks before surgery
- Randomised part: problems during surgery, such as a positive air-leak test or high blood loss
Read by machine on 9 November 2026.
Where in Sweden
- Skåne University HospitalMalmö, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Skane University Hospital
- Trial code
- NCT06214988
- Record updated
- 21 May 2025
- Original description
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.Read full original descriptionShow less
SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical 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.
Inclusion: 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: Previous pelvic irradiation (due to e.g. gynaecological or urological cancer); 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; Intraoperative blood loss ≥250 ml for minimally invasive surgery; Intraoperative blood loss ≥500 ml for open or converted surgery; Emergency rectal resection (tumour resection due to large bowel obstruction, perforation, etc); Preoperative tumour perforation or pelvic sepsis; 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); Insufficient command of Swedish, Norwegian, Danish or English to understand questionnaires or consent; Pregnancy or breastfeeding Additional exclusion criteria for randomised part of the study; 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; More than one intraabdominal anastomosis performed; Incomplete doughnuts; Air-leak test positive; TME with anastomosis ultimately not done.