Obstetrics and Gynaecology Unit 2U, Sant'Anna Hospital, AOU Città della Salute e della Scienza di Torino, Turin, Italy.
Obstetrics and Gynaecology Unit, Santa Croce e Carle Hospital, Cuneo, Italy.
BJOG. 2024 Aug;131(9):1207-1217. doi: 10.1111/1471-0528.17797. Epub 2024 Feb 25.
To 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.
A multi-centre, stepped-wedge cluster randomised trial (ClinicalTrials.gov NCT04063072).
Gynaecological units in the Piemonte region, Italy.
Patients undergoing elective hysterectomy, either for cancer or for benign conditions.
Twenty-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).
Length of hospital stay (LOS), without outliers (>98th percentile).
Between 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.
Implementation 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.
评估在一家区域医院网络中，通过强化术后康复（ERAS）方案并辅以密集的审核和反馈（A&F）措施，对接受择期子宫切除术的患者的有效性。
一项多中心、阶梯式楔形集群随机试验（ClinicalTrials.gov NCT04063072）。
意大利皮埃蒙特大区的妇科单位。
接受择期子宫切除术的患者，包括癌症或良性疾病。
将 23 个单位（集群）按手术量分层，随机分为 4 个序列。在基线（最初的 3 个月），所有单位均继续采用标准护理。随后，四个序列每隔 3 个月依次实施 ERAS 方案，在此之前先进行特定的培训。在研究结束时，每个单位都有一个时间段采用标准护理（对照），另一个时间段则采用协议（实验组）并辅以反馈。
住院时间（ LOS ），无异常值（>第 98 百分位数）。
2019 年 9 月至 2021 年 5 月，采用意向治疗方法对 2086 名患者进行了主要分析：对照组 1104 名（53%），实验组 982 名（47%）。ERAS 方案的依从性从对照组的 60%增加到实验组的 76%，调整后的绝对差异为+13.3%（95%CI 11.6%至 15.0%）。住院时间从 3.5 天缩短至 3.2 天，但无显著差异（-0.12 天；95%CI -0.30 至 0.07 天）。并发症的发生也没有差异。
在区域层面实施 ERAS 方案并辅以 A&F 措施，可显著提高依从性，但对 LOS 和并发症无明显影响。本研究证实了 A&F 在促进整个医院网络中的重要创新方面的有效性，并提示需要更高的 ERAS 方案依从性，以获得临床结果的有价值改善。
