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

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. Trial registration: ClinicalTrials.gov NCT04270721.