Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE) : Pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Journal article


ESCP EAGLE Safe Anastomosis Collaborative, NIHR Global Health Research Unit in Surgery and *Walsh, Adam. (2024). Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE) : Pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries. British Journal of Surgery. 111(1), p. Article znad370. https://doi.org/10.1093/bjs/znad370
AuthorsESCP EAGLE Safe Anastomosis Collaborative, NIHR Global Health Research Unit in Surgery and *Walsh, Adam
Abstract

Background
Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks.

Methods
The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned.

Results
A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31).

Conclusion
Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov).

Year2024
JournalBritish Journal of Surgery
Journal citation111 (1), p. Article znad370
PublisherOxford University Press
ISSN0007-1323
Digital Object Identifier (DOI)https://doi.org/10.1093/bjs/znad370
PubMed ID38029386
Scopus EID2-s2.0-85182638287
PubMed Central IDPMC10771257
Open accessPublished as ‘gold’ (paid) open access
FunderESCP
Ethicon
National Institute for Health Research (NIHR)
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online29 Nov 2023
Publication process dates
Accepted18 Oct 2023
Deposited10 Mar 2025
Supplemental file
License
File Access Level
Open
Grant IDNIHR133364
Additional information

*Australian Catholic University affiliated collaborator. See the article full text for a complete list of collaborators.

© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

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