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

IF 2.9 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Martin Rutegård, Marcus Lindsköld, Fredrik Jörgren, Kalle Landerholm, Peter Matthiessen, Håvard Mjørud Forsmo, Jennifer Park, Jacob Rosenberg, Johannes Schultz, Lars T. Seeberg, Josefin Segelman, Pamela Buchwald
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引用次数: 0

Abstract

Aim

Accumulated 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.

Methods

SELSA 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.

Conclusion

The 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 registration

Swedish 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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来源期刊
Colorectal Disease
Colorectal Disease 医学-胃肠肝病学
CiteScore
6.10
自引率
11.80%
发文量
406
审稿时长
1.5 months
期刊介绍: Diseases of the colon and rectum are common and offer a number of exciting challenges. Clinical, diagnostic and basic science research is expanding rapidly. There is increasing demand from purchasers of health care and patients for clinicians to keep abreast of the latest research and developments, and to translate these into routine practice. Technological advances in diagnosis, surgical technique, new pharmaceuticals, molecular genetics and other basic sciences have transformed many aspects of how these diseases are managed. Such progress will accelerate. Colorectal Disease offers a real benefit to subscribers and authors. It is first and foremost a vehicle for publishing original research relating to the demanding, rapidly expanding field of colorectal diseases. Essential for surgeons, pathologists, oncologists, gastroenterologists and health professionals caring for patients with a disease of the lower GI tract, Colorectal Disease furthers education and inter-professional development by including regular review articles and discussions of current controversies. Note that the journal does not usually accept paediatric surgical papers.
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