Article Text
Abstract
Introduction/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 practice. 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.
Methodology 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. Primary outcome was length of hospital stay (LOS) (without outliers).
Results 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.
Conclusion Implementation of the ERAS protocol for hysterectomy at the regional level, supported by an A&F approach, resulted in a substantial improvement in compliance. This improvement did not translate into relevant reduction of LOS, possibly due to the negative impact of COVID on hospital performance and above all to the short observation period. This study can serve as a replicable model for adopting a comprehensive A&F intervention to support and evaluate the implementation of ERAS in a large, unselected population such as that of a regional hospital network.
Disclosures The authors have no disclosures to declare. Funding: This work was supported by the Italian Ministry of Health (NET -2016–02364191) and Regione Piemonte (521-A14000) under the Easy-Net project.