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
(2025) In Colorectal Disease 27(4).- Abstract
Aim: The selective use of defunctioning stomas in anterior resection for rectal cancer hinges on accurately predicting anastomotic leakage. The aim of this study was to develop a prediction model for use in a prospective randomized clinical trial. Method: Colorectal Cancer Database (CRCBaSe) Sweden was used to identify patients who underwent low anterior resection for rectal cancer 2007–2021. Eligibility criteria mirrored the forthcoming SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA) trial, including patients <80 years of age and with American Society of Anaesthesiologists' (ASA) physical status grade of <III; further, patients without a defunctioning stoma were excluded. The outcome... (More)
Aim: The selective use of defunctioning stomas in anterior resection for rectal cancer hinges on accurately predicting anastomotic leakage. The aim of this study was to develop a prediction model for use in a prospective randomized clinical trial. Method: Colorectal Cancer Database (CRCBaSe) Sweden was used to identify patients who underwent low anterior resection for rectal cancer 2007–2021. Eligibility criteria mirrored the forthcoming SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA) trial, including patients <80 years of age and with American Society of Anaesthesiologists' (ASA) physical status grade of <III; further, patients without a defunctioning stoma were excluded. The outcome comprised anastomotic leakage within 30 days or in-hospital. Candidate predictors included age, sex, ASA grade, cardiovascular disease, diabetes, body mass index (BMI), tumour stage, tumour height, and neoadjuvant therapy. Seven models were developed and internally validated using bootstrapping. A threshold of a predicted leakage risk of ≤10% was chosen for trial implementation. Validation was conducted using chart-reviewed data from a nested cohort. Results: Of the 2727 eligible patients, 199 (7.3%) were registered with an anastomotic leakage. All models demonstrated similar performance, with prediction instability observed for risks exceeding 12.5%. The preferred model included three significant predictors: male sex (OR 2.00; 95% CI: 1.45–2.75), BMI >30 kg/m2 (OR 1.82; 95% CI: 1.21–2.74), and radiotherapy (OR 1.90; 95% CI: 1.35–2.69). The bootstrapped area under the curve (AUC) was 0.64 (95% CI: 0.62–0.65), with a negative predictive value of 94.6% (95% CI: 93.7%–95.6%). For the validation cohort, the corresponding estimates were 0.66 (95% CI: 0.59–0.74) and 89.5% (95% CI: 86.2%–92.5%). Conclusion: Accuracy of anastomotic leakage prediction using registry-based data is moderate; however, the model's ability to rule out a >10% risk is considered appropriate for trial use.
(Less)
- author
- Rutegård, Martin ; Myrberg, Ida Hed ; Nordenvall, Caroline ; Landerholm, Kalle ; Jörgren, Fredrik LU ; Matthiessen, Peter ; Park, Jennifer ; Segelman, Josefin ; Buchwald, Pamela LU and Häggström, Jenny
- organization
- publishing date
- 2025-04
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- anastomosis, diverting stoma, insufficiency, leakage, prediction, total mesorectal excision
- in
- Colorectal Disease
- volume
- 27
- issue
- 4
- article number
- e70089
- publisher
- John Wiley & Sons Inc.
- external identifiers
-
- scopus:105002459256
- pmid:40211676
- ISSN
- 1462-8910
- DOI
- 10.1111/codi.70089
- 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
- e4adebbe-8b96-4d52-b0d8-b6960ef82c53
- date added to LUP
- 2025-08-22 15:34:56
- date last changed
- 2025-08-23 04:02:55
@article{e4adebbe-8b96-4d52-b0d8-b6960ef82c53,
abstract = {{<p>Aim: The selective use of defunctioning stomas in anterior resection for rectal cancer hinges on accurately predicting anastomotic leakage. The aim of this study was to develop a prediction model for use in a prospective randomized clinical trial. Method: Colorectal Cancer Database (CRCBaSe) Sweden was used to identify patients who underwent low anterior resection for rectal cancer 2007–2021. Eligibility criteria mirrored the forthcoming SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA) trial, including patients <80 years of age and with American Society of Anaesthesiologists' (ASA) physical status grade of <III; further, patients without a defunctioning stoma were excluded. The outcome comprised anastomotic leakage within 30 days or in-hospital. Candidate predictors included age, sex, ASA grade, cardiovascular disease, diabetes, body mass index (BMI), tumour stage, tumour height, and neoadjuvant therapy. Seven models were developed and internally validated using bootstrapping. A threshold of a predicted leakage risk of ≤10% was chosen for trial implementation. Validation was conducted using chart-reviewed data from a nested cohort. Results: Of the 2727 eligible patients, 199 (7.3%) were registered with an anastomotic leakage. All models demonstrated similar performance, with prediction instability observed for risks exceeding 12.5%. The preferred model included three significant predictors: male sex (OR 2.00; 95% CI: 1.45–2.75), BMI >30 kg/m<sup>2</sup> (OR 1.82; 95% CI: 1.21–2.74), and radiotherapy (OR 1.90; 95% CI: 1.35–2.69). The bootstrapped area under the curve (AUC) was 0.64 (95% CI: 0.62–0.65), with a negative predictive value of 94.6% (95% CI: 93.7%–95.6%). For the validation cohort, the corresponding estimates were 0.66 (95% CI: 0.59–0.74) and 89.5% (95% CI: 86.2%–92.5%). Conclusion: Accuracy of anastomotic leakage prediction using registry-based data is moderate; however, the model's ability to rule out a >10% risk is considered appropriate for trial use.</p>}},
author = {{Rutegård, Martin and Myrberg, Ida Hed and Nordenvall, Caroline and Landerholm, Kalle and Jörgren, Fredrik and Matthiessen, Peter and Park, Jennifer and Segelman, Josefin and Buchwald, Pamela and Häggström, Jenny}},
issn = {{1462-8910}},
keywords = {{anastomosis; diverting stoma; insufficiency; leakage; prediction; total mesorectal excision}},
language = {{eng}},
number = {{4}},
publisher = {{John Wiley & Sons Inc.}},
series = {{Colorectal Disease}},
title = {{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}},
url = {{http://dx.doi.org/10.1111/codi.70089}},
doi = {{10.1111/codi.70089}},
volume = {{27}},
year = {{2025}},
}