TY - JOUR

T1 - Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

AU - ESCP EAGLE Safe Anastomosis Collaborative NIHR Global Health Research Unit in Surgery

AU - Avellaneda, Nicholas

AU - Al Masri, Mahmoud

AU - Baimakhanov, Abylai

AU - Balasubramaniam, Dinesh

AU - Bhangu, Aneel

AU - Bouchagier, Konstantinos

AU - Bozbiyik, Osman

AU - Carpelan, Anu

AU - Chwat, Carina

AU - Cunha, Miguel

AU - Dawson, Brett E

AU - Mallen, Maria Victoria Duque

AU - Ellebæk, Mark Bremholm

AU - Gonzalez, Tomás Elosua

AU - Elshami, Mohamedraed

AU - Fakhradiyev, Ildar

AU - Ozkan, Omer Faruk

AU - Fleres, Francesco

AU - Futaba, Kaori

AU - Gallo, Gaetano

AU - Ghosh, Dhruv

AU - Glasbey, James C

AU - Harrison, Ewen

AU - Hooper, Richard L

AU - Jain, Ritu

AU - Kamarajah, Sivesh

AU - Veetil, Sreejith Kannummal

AU - Kamer, Erdinc

AU - Keatley, James

AU - Knowles, Charles H

AU - Kulimbet, Mukhtar

AU - Lal, Pawanindra

AU - Li, Elizabeth

AU - Polamreddy, Bala Mahesh

AU - Minaya-Bravo, Ana

AU - Mittal, Rohin

AU - Morton, Dion Gregory

AU - Nadal, Luis Roberto Manzione

AU - Negoi, Ionut

AU - Nepogodiev, Dmitri

AU - Omar, Omar

AU - Pata, Francesco

AU - Pinkney, Thomas

AU - Potter, Mark A

AU - Rottoli, Matteo

AU - Santos, Guilherme

AU - Smith, Iain

AU - Лодыгин, Александр Владимирович

AU - Kopteyev, N. R.

AU - Ovchinnikov, Timofey

AU - Кащенко, Виктор Анатольевич

AU - Kuleshov, Oleg

AU - Pavlov, Rostislav

PY - 2023/11/29

Y1 - 2023/11/29

N2 - 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).

AB - 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).

UR - http://www.ncbi.nlm.nih.gov/pubmed/38029386

UR - https://www.mendeley.com/catalogue/5a1dbd0a-2402-3de5-824e-adb685e19efb/

U2 - https://doi.org/10.1093/bjs/znad370

DO - https://doi.org/10.1093/bjs/znad370

M3 - Article

JO - British Journal of Surgery

JF - British Journal of Surgery

SN - 0007-1323

ER -