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

被引:97
作者
Li, Elizabeth [1 ]
Bengueddach, A. [2 ]
Tidjane, A. [2 ]
Tabeti, B. [2 ]
Behilil, C. [2 ]
Boudjenan-Serradj, N. [2 ]
Bensafir, S. [2 ]
Meharzi, S. E., I [2 ]
Aissat, A. [3 ]
Ghouali, A. K. [3 ]
Larabi, K. [3 ]
Riffi, O. [3 ]
Kacimi, S. E. O. [3 ]
Mesli, S. N. [3 ]
Rezoug, W. [3 ]
Mitidieri, A. [4 ]
Jose, A. [4 ]
Pablo, C. [4 ]
Rodriguez, C. A. [4 ]
Panettiere, M. F. [4 ]
Barbalace, N. [4 ]
Juan, T. [4 ]
Lucena, J. [5 ]
Houdin, A. [5 ]
Fernandez, E. [5 ]
Lococo, J. [5 ]
Pedro, L. [5 ]
Loban, M. [5 ]
Vecchio, P. [5 ]
Grinblat, A. [6 ]
Carrie, A. [6 ]
Veracierto, F. [6 ]
Santillan, M. [6 ]
Napolitano, M. [6 ]
Avellaneda, N. [6 ]
La Rosa, S. [6 ]
Gonzalez, C. M. [7 ]
Ferro, E. [7 ]
Munoz, J. P. [7 ]
Ventorutti, T. [7 ]
Cabrera, C. [8 ]
Carrizo, C. [8 ]
Mospane, C. [8 ]
Leiro, F. [8 ]
Espino, J. [8 ]
Trama, M. [8 ]
Bianchi, R. [8 ]
Potolicchio, A. [9 ]
Dindri, F. [9 ]
Buey, L. [9 ]
机构
[1] Univ Birmingham, Inst Appl Hlth Res, NIHR Global Hlth Res Unit Global Surg, Birmingham B15 2TT, W Midlands, England
[2] Etab Hosp & Univ, Algiers, Algeria
[3] Univ Hosp Ctr, Oran, Algeria
[4] Churruca Visca, Buenos Aires, Argentina
[5] Grp Galeno, Buenos Aires, Argentina
[6] Hosp Univ Cemic, Buenos Aires, Argentina
[7] Nueva Proctol, Buenos Aires, Argentina
[8] Penna Hosp, Buenos Aires, Argentina
[9] Hosp Espanol Buenos Aires, Buenos Aires, Argentina
[10] Hosp Univ Austral, Pilar, Argentina
[11] Clin Univ Reina Fabiola, Cordoba, Argentina
[12] Hosp Privado Comunidad Mar Del Plata, Mar Del Plata, Argentina
[13] Hosp Luis Lagomaggiore, Mendoza, Argentina
[14] Sanatorio Laprida, Rosario, Argentina
[15] Dr Horacio E Oduber Hosp, Oranjestad, Aruba
[16] Bendigo Hlth, Bendigo, Vic, Australia
[17] Barmherzige Bruder Graz, Graz, Austria
[18] Med Univ Graz, Graz, Austria
[19] Leyla Med Ctr, Baku, Azerbaijan
[20] King Hamad Univ Hosp, Al Sayh, Bahrain
[21] Univ Clin Ctr Tuzla, Tuzla, Bosnia & Herceg
[22] Hosp Servidor Publ Estadual Francisco Morato de O, Vila Clementino, Brazil
[23] Felicio Rocho, Belo Horizonte, Brazil
[24] Univ Fed Minas Gerais, Hosp Clin, Ebserh, Belo Horizonte, Brazil
[25] Orizonti, Belo Horizonte, Brazil
[26] Policia Mil Estado Minas Gerais, Oncomed, Belo Horizonte, Brazil
[27] Santa Casa de Misericordia, Sao Paulo, Brazil
[28] Hosp Univ Sao Francisco de Assis Providencia Deus, Braganca Paulista, Brazil
[29] Hosp Univ Prof Polydoro Ernani de Sao Thiago Hu U, Florianopolis, Brazil
[30] Hosp Clin, Florianopolis, Brazil
[31] Hosp Univ Prof Edgard Santos, Salvador, Brazil
[32] Notre Dame Intermed Hosp Salvalus, Sao Paulo, Brazil
[33] Univ Hosp Dr Georgi Stranski, Pleven, Bulgaria
[34] Univ Hosp Eurohosp, Plovdiv, Bulgaria
[35] Univ Hosp Alexandrovska, Sofia, Bulgaria
[36] Zadar Gen Hosp, Zadar, Croatia
[37] Univ Hosp, Brno, Czech Republic
[38] Charles Univ Prague, Fac Med 2, Dept Surg, Prague, Czech Republic
[39] Motol Univ Hosp, Prague, Czech Republic
[40] Odense & Svendborg Univ Hosp, Odense, Denmark
[41] Alexandria Main Univ Hosp, Alexandria, Egypt
[42] Misr Canc Ctr, Cairo, Egypt
[43] Assiut Univ Hosp, Assiut, Egypt
[44] Ain Shams Univ, Specialized Hosp, Cairo, Egypt
[45] Ain Shams Univ Hosp, El Demerdash Hosp, Cairo, Egypt
[46] Gastrointestinal Surg Ctr, Cairo, Egypt
[47] Mansoura Univ, Oncol Ctr, Mansoura, Egypt
[48] Mansoura Univ Hosp, Mansoura, Egypt
[49] Maddawalabu Univ, Goba Referral Hosp, Robe, Ethiopia
[50] Kanta Hame Cent Hosp, Hameenlinna, Finland
基金
美国国家卫生研究院;
关键词
CLINICAL-TRIALS;
D O I
10.1093/bjs/znad370
中图分类号
R61 [外科手术学];
学科分类号
摘要
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).
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页数:18
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共 32 条
[1]  
[Anonymous], ASA PHYS STAT CLASS
[2]   Effectiveness of quality improvement collaboratives in UK surgical settings and barriers and facilitators influencing their implementation: a systematic review and evidence synthesis [J].
Atkins, Eleanor ;
Birmpili, Panagiota ;
Glidewell, Liz ;
Li, Qiuju ;
Johal, Amundeep S. ;
Waton, Sam ;
Boyle, Jon R. ;
Pherwani, Arun D. ;
Chetter, Ian ;
Cromwell, David A. .
BMJ OPEN QUALITY, 2023, 12 (02)
[3]  
Centers for Disease Control and Prevention. National Healthcare Safety Network, Surgical Site Infection Events (SSI)
[5]   Meta-analysis in clinical trials revisited [J].
DerSimonian, Rebecca ;
Laird, Nan .
CONTEMPORARY CLINICAL TRIALS, 2015, 45 :139-145
[6]   Risk factors for unfavourable postoperative outcome in patients with Crohn's disease undergoing right hemicolectomy or ileocaecal resection. An international audit by ESCP and S-ECCO [J].
El-Hussuna, Alaa .
COLORECTAL DISEASE, 2018, 20 (03) :219-227
[7]   The World Health Organization trauma checklist versus Trauma Team Time-out: A perspective [J].
Fitzgerald, Mark ;
Reilly, Stephanie ;
Smit, De Villiers ;
Kim, Yesul ;
Mathew, Joseph ;
Boo, Ellaine ;
Alqahtani, Abdulrahman ;
Chowdhury, Sharfuddin ;
Darez, Ahamed ;
Mascarenhas, Jma Bruno ;
O'Keeffe, Francis ;
Noonan, Michael ;
Nickson, Chris ;
Marquez, Marc ;
Li, Wang An ;
Zhang, Yan Ling ;
Williams, Kim ;
Mitra, Biswadev .
EMERGENCY MEDICINE AUSTRALASIA, 2019, 31 (05) :882-885
[8]   Risk Factors for Anastomotic Leak After Colon Resection for Cancer Multivariate Analysis and Nomogram From a Multicentric, Prospective, National Study With 3193 Patients [J].
Frasson, Matteo ;
Flor-Lorente, Blas ;
Ramos Rodriguez, Jose Luis ;
Granero-Castro, Pablo ;
Hervas, David ;
Alvarez Rico, Miguel Angel ;
Garcia Brao, Maria Jesus ;
Sanchez Gonzalez, Juan Manuel ;
Garcia-Granero, Eduardo .
ANNALS OF SURGERY, 2015, 262 (02) :321-330
[9]   Predictors for Anastomotic Leak, Postoperative Complications, and Mortality After Right Colectomy for Cancer: Results From an International Snapshot Audit [J].
Gallo G. ;
Pata F. ;
Vennix S. ;
Laurberg S. ;
Morton D. ;
Rubbini M. ;
Vaizey C. ;
Magill L. ;
Perry R. ;
Sheward N. ;
Hervas D. ;
Cillo M. ;
Estefania D. ;
Uriburu J.P. ;
Ruiz H. ;
Solomon M. ;
Makhmudov A. ;
Selnyahina L. ;
Varabei A. ;
Vizhynis Y. ;
Claeys D. ;
Defoort B. ;
Muysoms F. ;
Pletinckx P. ;
Vergucht V. ;
Debergh I. ;
Feryn T. ;
Reusens H. ;
Nachtergaele M. ;
Francart D. ;
Jehaes C. ;
Markiewicz S. ;
Monami B. ;
Weerts J. ;
Houben B. ;
Haeck L. ;
Lange C. ;
Sommeling C. ;
Vindevoghel K. ;
Castro S. ;
De Bruyn H. ;
Huyghe M. ;
De Wolf E. ;
Reynders D. ;
D'Hoore A. ;
De Buck Van Overstraeten A. ;
Wolthuis A. ;
Delibegovic S. ;
Christiani A. ;
Marchiori M., Jr. .
DISEASES OF THE COLON & RECTUM, 2020, 63 (05) :606-618
[10]   The impact of stapling technique and surgeon specialism on anastomotic failure after right-sided colorectal resection: an international multicentre, prospective audit [J].
Chaudhri, Sanjary .
COLORECTAL DISEASE, 2018, 20 (11) :1028-1040