Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
Surgical Oncology Department, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Torino, Italy.
BMJ Qual Saf. 2024 May 17;33(6):363-374. doi: 10.1136/bmjqs-2023-016594.
Enhanced recovery after surgery (ERAS) protocols are known to potentially improve the management and outcomes of patients undergoing colorectal surgery, with limited evidence of their implementation in hospital networks and in a large population. We aimed to assess the impact of the implementation of an ERAS protocol in colorectal cancer surgery in the entire region of Piemonte, Italy, supported by an audit and feedback (A&F) intervention.
A large, stepped wedge, cluster randomised trial enrolled patients scheduled for elective surgery at 29 general surgery units (clusters). At baseline (first 3 months), standard care was continued in all units. Thereafter, four groups of clusters began to adopt the ERAS protocol successively. By the end of the study, each cluster had a period in which standard care was maintained (control) and a period in which the protocol was applied (experimental). ERAS implementation was supported by initial training and A&F initiatives. The primary endpoint was length of stay (LOS) without outliers (>94th percentile), and the secondary endpoints were outliers for LOS, postoperative medical and surgical complications, quality of recovery and compliance with ERAS items.
Of 2626 randomised patients, 2397 were included in the LOS analysis (1060 in the control period and 1337 in the experimental period). The mean LOS without outliers was 8.5 days during the control period (SD 3.9) and 7.5 (SD 3.5) during the experimental one. The adjusted difference between the two periods was a reduction of -0.58 days (95% CI -1.07, -0.09; p=0.021). The compliance with ERAS items increased from 52.4% to 67.3% (estimated absolute difference +13%; 95% CI 11.4%, 14.7%). No difference in the occurrence of complications was evidenced (OR 1.22; 95% CI 0.89, 1.68).
Implementation of the ERAS protocol for colorectal cancer, supported by A&F approach, led to a substantial improvement in compliance and a reduction in LOS, without meaningful effects on complications. NCT04037787.
加速康复外科（ERAS）方案被认为有可能改善结直肠手术患者的管理和结局，但在医院网络和大量人群中实施的证据有限。我们旨在评估在意大利皮埃蒙特地区实施结直肠癌手术 ERAS 方案的影响，该方案得到了审核和反馈（A&F）干预的支持。
一项大型、阶梯式、集群随机试验纳入了在 29 个普通外科单位（集群）接受择期手术的患者。在基线（前 3 个月），所有单位均继续采用标准护理。此后，4 组集群相继开始采用 ERAS 方案。研究结束时，每个集群都有一个采用标准护理的时期（对照组）和一个采用方案的时期（实验组）。ERAS 的实施得到了初步培训和 A&F 措施的支持。主要终点是无离群值（>第 94 百分位数）的住院时间（LOS），次要终点是 LOS 的离群值、术后医疗和手术并发症、恢复质量和 ERAS 项目的依从性。
在 2626 名随机患者中，2397 名患者纳入 LOS 分析（对照组 1060 名，实验组 1337 名）。对照组的平均 LOS 无离群值为 8.5 天（标准差 3.9），实验组为 7.5 天（标准差 3.5）。两个时期之间的调整差异为减少 0.58 天（95%CI-1.07，-0.09；p=0.021）。ERAS 项目的依从性从 52.4%增加到 67.3%（估计绝对差异+13%；95%CI11.4%，14.7%）。没有证据表明并发症的发生率有差异（比值比 1.22；95%CI0.89，1.68）。
在审核和反馈措施的支持下，实施结直肠癌 ERAS 方案导致依从性显著提高和 LOS 缩短，而对并发症没有明显影响。NCT04037787。
