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. (25th August 2021)

• Record Type: Journal Article
• Other Names: Soares António Sampaio investigator.; Garmanova Tatiana investigator.; Gravante Gianpiero investigator.; Bywater Edward investigator.; Pettitt Michala investigator.; Venn Mary L. investigator.; Glasbey James C. investigator.; Nepogodiev Dmitri investigator.; Li Elizabeth investigator.; Minaya‐Bravo Ana investigator.; Negoi Ionut investigator.; Frasson Matteo investigator.; Hooper Richard L. investigator.; Knowles Charles H. investigator.; Morton Dion Gregory investigator.; Bhangu Aneel investigator.; Dawson Brett E. investigator.; Keatley James investigator.; Magill Laura investigator.; Perry Rita investigator.; Pinkney Thomas investigator.; Potter Mark A. investigator.; Evans Jonathan P. investigator.; Kamarajah Sivesh investigator.; McKay Siobhan C. investigator.; Osei‐Bordom Daniel investigator.; Chaudhri Sanjay investigator.; Sánchez‐Guillén Luis investigator.; Stijns Jasper investigator.; Loon Yu Ting Van investigator.; Hahnloser Dieter investigator.; Zimmerman David D. E. investigator.; Buchs Nicolas C. investigator.; Cato Liam investigator.; Cunha Miguel investigator.; El‐Sayed Charlotte investigator.; Finch David investigator.; Gallo Gaetano investigator.; Martins Ruben investigator.; Neary Peter Mark investigator.; Pata Francesco investigator.; Poskus Tomas investigator.; Roslani April C. investigator.; Samadov Elgun investigator.; Sbaih Mohammed investigator.; Shalaby Mostafa investigator.; Simões Joana investigator.; Sinha Aaditya Prakash investigator.; Sivrikoz Emre investigator.; Vardanyan Armen investigator.; Spinelli Antonino investigator.; Beard David J. investigator.; Campbell Marion investigator.; Omar Omar investigator.; Sinha Aaditya investigator.;
• Is Part Of: Colorectal disease. Volume 23:Number 10(2021)
• Page Start: 2761
• Page End: 2771
• Publication Date: 2021-08-25
• Subjects: anastomotic leak -- colorectal surgery -- dog‐leg cluster randomised -- quality improvement study -- randomised trial -- right hemicolectomy; Colon (Anatomy) -- Diseases -- Periodicals; Rectum -- Diseases -- Periodicals; 616.34
• DOI: 10.1111/codi.15806
• Languages: English
• ISSNs: 1462-8910

Abstract

Abstract: 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.