Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

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

Rutegård, Martin ; Lindsköld, Marcus LU ; Jörgren, Fredrik LU ; Landerholm, Kalle ; Matthiessen, Peter ; Forsmo, Håvard Mjørud ; Park, Jennifer ; Rosenberg, Jacob ; Schultz, Johannes and Seeberg, Lars T. , et al. (2025) In Colorectal Disease 27(2).
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... (More)

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).

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
anastomotic leakage, diverting, rectal cancer, stoma, TME
in
Colorectal Disease
volume
27
issue
2
article number
e70009
publisher
John Wiley & Sons Inc.
external identifiers
  • scopus:85216857322
  • pmid:39887540
ISSN
1462-8910
DOI
10.1111/codi.70009
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2025 The Author(s). Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.
id
7d07961e-aa9a-40c5-af52-1db8c48bf772
date added to LUP
2025-04-09 09:41:31
date last changed
2025-07-16 17:30:51
@article{7d07961e-aa9a-40c5-af52-1db8c48bf772,
  abstract     = {{<p>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 &lt;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).</p>}},
  author       = {{Rutegård, Martin and Lindsköld, Marcus and Jörgren, Fredrik and Landerholm, Kalle and Matthiessen, Peter and Forsmo, Håvard Mjørud and Park, Jennifer and Rosenberg, Jacob and Schultz, Johannes and Seeberg, Lars T. and Segelman, Josefin and Buchwald, Pamela}},
  issn         = {{1462-8910}},
  keywords     = {{anastomotic leakage; diverting; rectal cancer; stoma; TME}},
  language     = {{eng}},
  number       = {{2}},
  publisher    = {{John Wiley & Sons Inc.}},
  series       = {{Colorectal Disease}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1111/codi.70009}},
  doi          = {{10.1111/codi.70009}},
  volume       = {{27}},
  year         = {{2025}},
}