Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial.

IF 5.6 1区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Eva Pagano, Luca Pellegrino, Manuela Robella, Anna Castiglione, Francesco Brunetti, Lisa Giacometti, Monica Rolfo, Alessio Rizzo, Sarah Palmisano, Maurizio Meineri, Ilaria Bachini, Mario Morino, Marco Ettore Allaix, Alfredo Mellano, Paolo Massucco, Paola Bellomo, Roberto Polastri, Giovannino Ciccone, Felice Borghi
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引用次数: 0

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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. Trial registration number NCT04037787.

在审计和反馈支持下,在地区医院网络中实施结直肠癌术后强化恢复方案:阶梯式楔形群随机试验。
背景:众所周知,加强术后恢复(ERAS)方案有可能改善结直肠手术患者的管理和治疗效果,但在医院网络和大量人群中实施该方案的证据有限。我们的目的是评估在意大利皮埃蒙特大区实施结直肠癌手术ERAS方案的影响,并辅以审计和反馈(A&F)干预措施:一项大型阶梯式楔形群组随机试验招募了 29 个普外科单位(群组)的择期手术患者。在基线期(头 3 个月),所有单位都继续执行标准护理。此后,四个分组开始相继采用 ERAS 方案。到研究结束时,每个组都有一个维持标准护理的阶段(对照组)和一个采用该方案的阶段(实验组)。ERAS 的实施得到了初始培训和 A&F 计划的支持。主要终点是无异常值(大于第94百分位数)的住院时间(LOS),次要终点是住院时间异常值、术后内外科并发症、恢复质量和ERAS项目依从性:在 2626 名随机抽取的患者中,有 2397 名纳入了住院时间分析(对照组 1060 人,实验组 1337 人)。无异常值的平均住院日为:对照期 8.5 天(标清 3.9 天),实验期 7.5 天(标清 3.5 天)。两个时期的调整后差异为-0.58天(95% CI -1.07, -0.09;P=0.021)。ERAS项目的符合率从52.4%提高到67.3%(估计绝对差异+13%;95% CI 11.4%,14.7%)。并发症发生率无差异(OR 1.22;95% CI 0.89,1.68):结论:在A&F方法的支持下,结直肠癌ERAS方案的实施大大提高了患者的依从性,缩短了住院时间,但对并发症没有明显影响。
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来源期刊
BMJ Quality & Safety
BMJ Quality & Safety HEALTH CARE SCIENCES & SERVICES-
CiteScore
9.80
自引率
7.40%
发文量
104
审稿时长
4-8 weeks
期刊介绍: BMJ Quality & Safety (previously Quality & Safety in Health Care) is an international peer review publication providing research, opinions, debates and reviews for academics, clinicians and healthcare managers focused on the quality and safety of health care and the science of improvement. The journal receives approximately 1000 manuscripts a year and has an acceptance rate for original research of 12%. Time from submission to first decision averages 22 days and accepted articles are typically published online within 20 days. Its current impact factor is 3.281.
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