Affiliation:
1. Obstetrics and Gynaecology Unit 2U Sant'Anna Hospital, AOU Città della Salute e della Scienza di Torino Turin Italy
2. Obstetrics and Gynaecology Unit Santa Croce e Carle Hospital Cuneo Italy
3. Obstetrics and Gynaecology Unit Martini Hospital, ASL Città di Torino Turin Italy
4. Clinical Epidemiology Unit AOU Città della Salute e della Scienza di Torino and CPO Piemonte Torino Italy
5. Healthcare Services Direction Humanitas Gradenigo Torino Italy
6. General Surgery and Oncology Unit Mauriziano Hospital Turin Italy
7. Department of Surgical Sciences Sant'Anna Hospital, University of Turin Turin Italy
Abstract
AbstractObjectiveTo evaluate the effectiveness of implementing the Enhanced Recovery After Surgery (ERAS) protocol in patients undergoing elective hysterectomy in a network of regional hospitals, supported by an intensive audit‐and‐feedback (A&F) approach.DesignA multi‐centre, stepped‐wedge cluster randomised trial (ClinicalTrials.gov NCT04063072).SettingGynaecological units in the Piemonte region, Italy.PopulationPatients undergoing elective hysterectomy, either for cancer or for benign conditions.MethodsTwenty‐three units (clusters), stratified by surgical volume, were randomised into four sequences. At baseline (first 3 months), standard care was continued in all units. Subsequently, the four sequences implemented the ERAS protocol successively every 3 months, after specific training. By the end of the study, each unit had a period in which standard care was maintained (control) and a period in which the protocol, supported by feedback, was applied (experimental).Main outcome measuresLength of hospital stay (LOS), without outliers (>98th percentile).ResultsBetween September 2019 and May 2021, 2086 patients were included in the main analysis with an intention‐to‐treat approach: 1104 (53%) in the control period and 982 (47%) in the ERAS period. Compliance with the ERAS protocol increased from 60% in the control period to 76% in the experimental period, with an adjusted absolute difference of +13.3% (95% CI 11.6% to 15.0%). LOS, moving from 3.5 to 3.2 days, did not show a significant reduction (−0.12 days; 95% CI −0.30 to 0.07 days). No difference was observed in the occurrence of complications.ConclusionsImplementation of the ERAS protocol for hysterectomy at the regional level, supported by an A&F approach, resulted in a substantial improvement in compliance, but without meaningful effects on LOS and complications. This study confirms the effectiveness of A&F in promoting important innovations in an entire hospital network and suggests the need of a higher compliance with the ERAS protocol to obtain valuable improvements in clinical outcomes.