ArticleColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland2025
SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision.
Article in Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06214988 (SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
SELective Defunctioning Stoma Approach in Low Anterior Resection for Rectal Cancer (SELSA): a Prospective Study With a Nested Randomised Clinical Trial
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Management of anastomotic leak after elective anterior resection for rectal cancer: A systematic review and pooled analysis.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025Pooled it
- Development and validation of an anastomotic risk score for use in a randomized clinical trial on defunctioning stoma use in low anterior resection for rectal cancer.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025Trial
- Robotic vs. Laparoscopic Stapling in Robotic Total Mesorectal Excision: A Prospective Cohort Study.Cureus · 2026Article
- Prevention and management of anastomotic leakage after colorectal resection: evolving trends among Italian surgeons. A SICCR survey.Updates in surgery · 2026Article
- Safety and effectiveness of the Colovac anastomosis protection device compared with diverting ileostomy after low anterior resection: protocol for an international, multicentre, prospective, non-randomised comparative study (SAFE-3).BMJ open gastroenterology · 2026Article
- A risk prediction model for overall and Grade C anastomotic leakage after rectal cancer surgery.Frontiers in oncology · 2026Article
- Vacuum-assisted self-expanding stents in colorectal surgery: early experiences with a novel tool.Surgical endoscopy · 2025Article
- SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025Article
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Authors and funding
12 authors.
Funding
Abstract
aimAccumulated data suggest that routine use of defunctioning stoma in low anterior resection for rectal cancer may cause kidney injury, bowel dysfunction and a higher risk of permanent stomas. We aim to study whether avoidance of a diverting stoma in selected patients is safe and reduces adverse consequences.
methodsSELSA is a multicentre international prospective observational study nesting an open-label randomized clinical trial. All patients with primary rectal cancer planned for low anterior resection are eligible. Patients operated with curative intent, aged <80 years, with an American Society of Anaesthesiologists' fitness grade I or II, and a low predicted risk of anastomotic leakage are eligible to 1:1 randomization between no defunctioning stoma (experimental arm) or a defunctioning stoma (control arm). The primary 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 score, and permanent stoma rate. 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. Patient inclusion will commence in the autumn of 2024.
conclusionThe SELSA study is investigating a tailored approach to defunctioning stoma use in low anterior resection for rectal cancer in relation to the risk of anastomotic leakage. Our hypothesis is that long-term effects will favour the selective approach, enabling some patients to avoid a defunctioning stoma.
trial registrationSwedish Ethical Review Authority approval (2023-04347-01, 2024-02418-02 and 2024-03622-02), Regional Ethics Committee Denmark (H-24014463), and ClinicalTrials.gov (NCT06214988).
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