Clinical Epidemiology Unit and CPO Piemonte, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
Department of Surgery, General and Oncologic Surgery Unit, Santa Croce e Carle Hospital, Cuneo, Italy.
BMJ Open. 2021 Jun 3;11(6):e047491. doi: 10.1136/bmjopen-2020-047491.
The ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population.
A multicentre stepped wedge cluster randomised trial is designed for comparison between standard perioperative management and the management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of postoperative complications, time to patients' recovery, control of pain and patients' satisfaction. With an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study web site. The study includes 28 surgical centres, stratified by activity volume and randomly divided into four groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There are four activation periods, one every 3 months. However, the planned calendar and the total duration of the study have been extended by 6 months due to the COVID-19 pandemic.The expected sample size of about 2200 patients has a high statistical power (98%) to detect a reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints.
The study protocol has been approved by the Ethical Committee of the coordinating centre and by all participating centres. Study results will be timely circulated within the hospital network and published in peer-reviewed journals.
NCT04037787.
ERAS 方案（术后强化康复）是一种多模式的途径，旨在减轻手术应激，促进术后快速康复。ERAS 方案在意大利的少数医院中应用于结直肠癌手术。为了在皮埃蒙特整个地区医院网络中系统地采用 ERAS，采用了审核和反馈（A&F）方法，并结合了一项集群随机试验，以估计该方案对大量未选择人群的真实影响。
设计了一项多中心阶梯式楔形集群随机试验，以比较标准围手术期管理与根据 ERAS 方案进行的管理。主要结局是住院时间（LOS）。次要结局是：术后并发症发生率、患者恢复时间、疼痛控制和患者满意度。通过 A&F 方法，通过研究网站上的一个专门区域监测对 ERAS 项目的依从性。该研究包括 28 个外科中心，按活动量分层，并随机分为四组。每组随机分配到 ERAS 方案的不同激活期。有四个激活期，每 3 个月一个。然而，由于 COVID-19 大流行，计划的日程和总研究时间延长了 6 个月。预计约 2200 例患者的样本量具有很高的统计学效能（98%），可检测到 LOS 减少 1 天，并估计其他终点的临床有意义的变化。
该研究方案已得到协调中心伦理委员会和所有参与中心的批准。研究结果将及时在医院网络内传播，并在同行评议期刊上发表。
NCT04037787。
