Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE)

• Verfasst von: Avellaneda, Nicholas [VerfasserIn]
• Verfasst von: Fütterer, Carsten Dietmar [VerfasserIn]
• Verfasst von: Reißfelder, Christoph [VerfasserIn]
• Verfasst von: Şandra-Petrescu, Flavius Ionuţ [VerfasserIn]
• Verfasst von: Herrle, Florian [VerfasserIn]
• Verfasst von: Hardt, Julia [VerfasserIn]
• Verfasst von: Lamm, Lena [VerfasserIn]
• Verfasst von: Seyfried, Steffen [VerfasserIn]
• Titel: Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE)
• Titelzusatz: pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries : randomized clinical trial
• Verf.angabe: ESCP EAGLE Safe Anastomosis Collaborative and NIHR Global Health Research Unit in Surgery
• E-Jahr: 2024
• Jahr: January 2024
• Umfang: 18 S.
• Fussnoten: Online veröffentlicht: 29. November 2023 ; Collaborators (country in alphabetical order, and hospital): Germany: A. Hoetzel, A. Jud, D. Jauch, F-F. Stefan, H. Neeff, P. Holzner, P. Nguyen (University Hospital Freiburg), A. Ryl, F. Kehl, F. Pullig, J. Baral, S. Münch (Klinikum Karlsruhe), C. Fütterer, C. Reißfelder, F. Sandra-Petrescu, F. Herrle, J. Hardt, L. Lamm, S. Seyfried (Mannheim University Medical Center (Universitätsmedizin Mannheim)), A. Gharbi, F. Aydin, G. Stavrou, J. Sperber, J. de Deken, K. Schwarzkopf, R. Widyaningsih (Klinikum Saarbruecken) ; Gesehen am 30.09.2024
• Titel Quelle: Enthalten in: The British journal of surgery
• Ort Quelle: Oxford : Oxford University Press, 1913
• Jahr Quelle: 2024
• Band/Heft Quelle: 111(2024), 1 vom: Jan., Artikel-ID znad370, Seite 1-18
• ISSN Quelle: 1365-2168
• DOI: doi:10.1093/bjs/znad370
• Datenträger: Online-Ressource
• Sprache: eng
• Bibliogr. Hinweis: Errata: Avellaneda, Nicholas: Corrigendum to: Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries
• K10plus-PPN: 1903783984

Abstract

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