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).
Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries
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Umar Masoro; Adegbolahan Fakoya; David Irabor; Florence Anyadike; Ikechukwu Ulasi; Mathias Orji; Oludolapo Afuwape; Omobolaji Ayandipo; Isiaka Aremu; Kazeem Adegboye; Peter Gbadegesin; Bashiru Aminu; Ifeanyi Kene Aghadi; Jerry Godfrey Makama; Samaila Joshua; Stephen Akau Kache; Abdulrahman Abba Sheshe; Abubakar Muhammad Bala; Ibrahim Umar Garzali; Mustapha Miko Mohammed Abdullahi; Nasiru Muhammad; Nura Aliyu Umar; Saminu Muhammad; Aloysius Okoye; Chiemelu Emegoakor; Chimdiebele Nwosu; Ochonma Amobi Egwuonwu; Okechukwu Ekwunife; Rita Amadigwe; Samuel Ojiakor; Abidemi Akere; Chukwuma Okereke; Oluwaseun Olaleye; Oluwasuyi Ige; Oyetunde Olubayo; Tope Olatiilu; Mohammad Idris; Ahmad Shehu; Dupe Oluyori; Emeka Nwabuoku; Linus Ukwubile; Mohammed Bashir; Muhammad Daniyan; Hareem Rauf; Madeeha Ali; Maheen Zakaria; Malika Hameed; Nazli Amanullah; Tabish Chawla; Usama Waqar; Abid Jamal; Anam Butt; Asad Kerawala; Samuel Samson; Afia Arshed Dodhy; Aun Jamal Gill; Awais Malik; Danish Ali; Hassan Mohsin; 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Madalena Sanches; Sandra Oliveira; Victor Baptista; Alberto Roxo; Helena Devesa; Olena Teslyak; Renato Barradas; Sónia Marques; Sónia Martins; Susana Pepino; Alberto Silva; Ana Cláudia Deus; Andreia Ferreira; Diogo Marinho; Diogo Sousa; Maria João Martins; Nuno Matias; Aurora Pinto; Débora Correia; Fabíola Amado; Lisbete Cordeiro; Manuel Morales; Marta Lamas; Sérgio Marçal; Ana Isabel Rodrigues; Anabela Santos; André Marçal; António Oliveira; Carina Gomes; Cátia Ferreira; Rita Marques; Andrei Chitul; Corina Alexandrescu; Cosmin Bezede; Daniel Cristian; Draga Mandi; Florin Grama; Raluca Ungureanu; Bogdan Stoica; Cati Diaconescu; Cezar Ciubotaru; Ioan Tanase; Ioana Grintescu; Valentina Madalina Negoita; Camelia Calin; Catalina Simeanu; Danut Constantin Ciotarla; Mihaela Caltea; Radu Mihail Mirica; Anamaria Luca; Andrei Pasca; Catalin Vlad; Eduard-Alexandru Bonci; Ioana Stefanescu; Patriciu Andrei Achimas-Cadariu; Vlad Alexandru Gata; Alina Capusan; Cristina Petrisor; George Dindelegan; Radu Seicean; Razvan Scurtu; Vasile Bintintan; Vlad Fagarasan; Calin Ionescu; Dana Crisan; Loredana Zanc; Mihaela-Valentina Ene-Cocis; Mihai-Stefan Muresan; Sebastian Mihai Mihalcea; Vlad Dudric; Ana-Maria Musina; Anca-Irina Ristescu; Cristian-Ene Roata; Mihaela Moglan; Mihail-Gabriel Dimofte; Sorinel Lunca; Stefan Iacob; Aleksander Dychko; Andrey Litvin; Anna Kapustina; Arina Provozina; Evgeny Anokhin; Mikhail Zabiyaka; Alexander Shin; Khasan Djumabayev; Marina Kuznetsova; Sergey Gordeyev; Sofia Kochkina; Zaman Mamedli; Daniil Markaryan; Eduard Galliamov; Ekaterina Semina; Mihail Agapov; Pavel Malahov; Tatiana Garmanova; Viktor Kakotkin; Andrey Zaycev; Anton Sumbaev; Arkady Bedzhanyan; Evgenya Orman; Konstantin Petrenko; Mikhail Bredikhin; Yulia Frolova; Inna Tulina; Olga Bashilkina; Petr Tsarkov; Sergey Rodimov; Vitaliy Stamov; Vladimir Balaban; Abelevich Alexnder; Alexey Yanishev; Dmitrii Rogozhev; Natalia Yakunina; Natlia Chubukova; Ruslan Nugmanov; Aleksei Karachun; Aleksei Petrov; Andrei Domanskiy; Lidiia Panaiotti; Marina Smolina; Tatyana Sapronova; Yuriy Pelipas; Eugeny Zagaynov; Gleb Khrykov; Larisa Davidovskaja; Nikita Burlov; Nikolay Mankevich; Tatyana Tverdohlebova; Alexander Bogatikov; Alexander V Lodygin; Constantin Krasnoselsky; Evgeniia-Surgeon Vasiukova; Nikita R Kopteyev; Timofey Ovchinnikov; Victor A Kashchenko; Anastasia Novikova; Ekaterina Terentyeva; Oleg Kuleshov; Rostislav Pavlov; Andrey Koshel; Dmitry Kostromitsky; Evgeniy Drozdov; Sergey Klokov; Amparo Camacho; Farhat N Khan; Mahdi Al Bandar; Rafia Shamim; Sharfuddin Chowdhury; Bojan Kovacevic; Igor Krdzic; Maja Zdravkovic; Marko Kenic; Milica Milentijevic; Natasa Petkovic; Radosav Radulovic; James Ngu; Nan Zun Teo; Prit Anand Singh; Suet Yan Ong; Sun Li; Bei En Siew; Corissa Chee; Jasmin Jia Min Koh; Kai Yin Lee; Ker Kan Tan; Siew Ching Wong; Will Loh; Andrea Fernandez Pujol; Javier Corral Rubio; Laia Pagés Farrés; Laura Lopez Vendrell; Maria Inmaculada Ureña Del Olmo; Ana Belen Pedregosa; Carla Galmes; Daiva Luckute; Daniel Casanova; Mariano Artigot; Xavier Guedes; Yolanda Olivella; Marc Sadurni Sarda; Marta Jimenez Toscano; Marta Pascual Damieta; Miguel Pera; Sandra Alonso Gonçalvez; Sandra Torres Galvez; Silvia Salvans Ruiz; Eloy Espin-Basany; Franco Marinello; Laura Villarino-Villa; Marisol Vega-Las Heras; Rocio Martin-Sanchez; Rodrigo Mata Mata;