NCT06214988Recruiting
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
Source: ClinicalTrials.gov · Last updated 21 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- First submitted
- 17 Dec 2023
- Start date
- 1 Sept 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Skane University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06214988
What you commit to
- Study type: Interventional
- Planned participants: 212
- From 1 Sept 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.