ESCP safe anastomosis proGramme in coLorectal surgEry (EAGLE): Study protocol for an international cluster randomised trial of a quality improvement intervention to reduce anastomotic leak following right colectomy

Soares, António Sampaio and Garmanova, Tatiana and Gravante, Gianpiero and Bywater, Edward and Pettitt, Michala and Venn, Mary L. and Glasbey, James C. and Nepogodiev, Dmitri and Li, Elizabeth and Minaya‐Bravo, Ana and Negoi, Ionut and Frasson, Matteo and Hooper, Richard L. and Knowles, Charles H. and Morton, Dion Gregory and Bhangu, Aneel and Dawson, Brett E. and Keatley, James and Magill, Laura and Perry, Rita and Pinkney, Thomas and Potter, Mark A. and Evans, Jonathan P. and Kamarajah, Sivesh and McKay, Siobhan C. and Osei‐Bordom, Daniel and Chaudhri, Sanjay and Sánchez‐Guillén, Luis and Stijns, Jasper and Loon, Yu Ting Van and Hahnloser, Dieter and Zimmerman, David D. E. and Buchs, Nicolas C. and Cato, Liam and Cunha, Miguel and El‐Sayed, Charlotte and Finch, David and Gallo, Gaetano and Martins, Ruben and Neary, Peter Mark and Pata, Francesco and Poskus, Tomas and Roslani, April C. and Samadov, Elgun and Sbaih, Mohammed and Shalaby, Mostafa and Simões, Joana and Sinha, Aaditya Prakash and Sivrikoz, Emre and Vardanyan, Armen and Spinelli, Antonino and Beard, David J. and Campbell, Marion and Omar, Omar and Sinha, Aaditya (2021) ESCP safe anastomosis proGramme in coLorectal surgEry (EAGLE): Study protocol for an international cluster randomised trial of a quality improvement intervention to reduce anastomotic leak following right colectomy. Colorectal Disease, 23 (10). pp. 2761-2771. ISSN 1462-8910, DOI

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Aim Cohort data suggest that anastomotic leak occurs after 8% of right colectomies causing significant morbidity and mortality. Patient selection, intra-operative factors, and technical variation all contribute to risk of leak. The EAGLE study will assess whether implementation of the European Society of Coloproctology (ESCP) Safe Anastomosis Intervention reduces anastomotic leak following right colectomy. Methods An international, multi-centre, cluster randomised trial will be undertaken with hospitals as clusters. Hospitals will be recruited in a number of distinct phases, with each phase following the same research plan, in which clusters are randomised to one of three, staggered (dog-leg) schedules for implementation of the Safe Anastomosis Intervention. Results Results from different phases will be meta-analysed. The intervention is a three-component behavioural change programme for surgeons, anaesthetists and operating room staff, supported by an online learning environment. All colorectal surgical units around the world will be eligible. Adults undergoing elective or emergency right colectomy or ileocaecal resection, by any approach and for any indication will be included. The primary outcome is 30-day anastomotic leak rate, defined as clinical or radiologically-detected leak or intra-abdominal or pelvic collection. Assuming hospitals provide data for an average of 10 patients per two month recruitment period, 333 clusters (4440 patients in total) will allow for detection of an absolute risk reduction of anastomotic leak from 8.1% to 5.6% (relative risk reduction 30%). This protocol adheres to Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT). Discussion The protocol describes the methods for an evaluation of a hospital-level, education-based quality improvement intervention targeted to reduce the life-threatening surgical complication of anastomotic leak.

Item Type: Article
Funders: European Society of Coloproctology (ESCP), Ethicon
Uncontrolled Keywords: Anastomotic leak; Colorectal surgery; Dog-leg cluster randomised; Quality improvement study; Randomised trial; Right hemicolectomy
Subjects: R Medicine > R Medicine (General)
R Medicine > RD Surgery
Divisions: Faculty of Medicine
Depositing User: Ms. Juhaida Abd Rahim
Date Deposited: 17 Feb 2022 07:42
Last Modified: 17 Feb 2022 07:42

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