Summary of the EAGLE trial
ANASTOMOTIC LEAK
Any surgical units that routinely perform both elective and emergency right colectomy in adult patients were eligible to enrol on the study. A surgical consultant, surgical trainee, an anaesthetist and a nurse principle investigator were required as a minimum in each local team (cluster). The primary objective was to reduce 30-day anastomotic leak rate following right colectomy. Clusters were randomised in a series of batches or phases approximately every 2 months, provided at least 18 clusters were ready (batches varied in size). In each batch, clusters were randomised 1:1:1 to three different sequences, with data collection in two distinct 2-month calendar periods (Fig. Incomplete stepped wedge study design timeline. Example timeline for a single phase or batch in the trial. The figure shows the incomplete dog-leg study design. Sequence randomisation takes place when clusters have enrolled and are ready to begin the study. This model is repeated multiple times with ‘time 0’ being reset for each new batch. Note: new patients are collected for 2 months in each data collection period with outcomes followed up to 30 days afterThe hospital-level intervention required all surgeons to complete online education modules and then with their surgical teams to implement the ‘ESCP Safe Anastomosis Intervention’. The intervention was comprised of three components: pre-operative risk stratification, harmonisation of surgical technique and an intra-operative ‘ESCP Safe Anastomosis checklist’. Data collection involved identification and enrolment of all consecutive patients ≥ 18 years undergoing right colectomy with or without anastomosis in the defined data collection period, and follow-up until 30 postoperative days. As this was a hospital-level educational intervention, patient-level consent was not necessary in most jurisdictions. EAGLE was prospectively registered, IRAS ID:272,250; ClinicalTrials.gov, identifier NCT04270721 and the full protocol is published elsewhere [