Implementing Enhanced Recovery after Surgery-ERAS Protocol for Hysterectomy with Audit and Feedback. A Stepped Wedge Cluster Randomised Trial

Background: The audit-and-feedback (A&F) approach is a key component of the perioperative protocol ERAS (Enhanced Recovery After Surgery) that is often neglected in practise. Few studies evaluated the effectiveness of implementing the ERAS protocol at the regional level, supported by an intensive A&F approach, with an appropriate cluster-randomised design.Methods: A multi-center stepped wedge cluster randomised trial was conducted in 23 regional hospitals in Piemonte (Italy). Patients undergoing elective hysterectomy, either for cancer or for benign conditions (other than pelvic floor disorders), were eligible. Gynaecologic units (study clusters), stratified by surgical volume, were randomised into 4 groups that progressively adopted the ERAS protocol every 3 months, after specific training. Randomisation was performed by the Clinical Epidemiology unit. Blinding of group allocation to participants, care providers, and researchers was not possible. Primary outcome was length of hospital stay (without outliers). Trial Registration: Clinicaltrials.gov (NCT04063072).Findings: Between September 2019 and May 2021, 2084 patients were included in the main analysis with an intention-to-treat approach, 1104 (53%) in the control period and 980 (47%) in the ERAS period. Compliance to ERAS protocol increased from 60% to 76%, with an adjusted absolute difference of 13·3 points (95%CI: 11·62; 15·03). The ERAS protocol contributed slightly to reduce mean LOS from 3·5 to 3·2 days, with an adjusted reduction of -0·12 days (95%CI: -0·32; 0·08). No difference was observed in the occurrence of complications.Interpretation: Implementation of the ERAS protocol for hysterectomy at the regional level, supported by an A&F approach, resulted in a substantial improvement in compliance. Possibly due to the negative impact of COVID on hospital performance, this improvement did not translate into relevant clinical benefits.Trial Registration: Clinicaltrials.gov (NCT04063072).Funding: Support from the Italian Ministry of Health (NET -2016-02364191) and Regione Piemonte (521-A14000) under the Easy-Net project.Declaration of Interest: We declare no competing interests.Ethical Approval: For the promoting centre the approval was granted by the Ethic committee of A.O. Santa Croce e Carle di Cuneo with the reference n. 9-18 dated 06/06/2018. The study was approved by the ethics committees of all participating centres and written informed consent was obtained from all eligible patients.