Lozano Blesa University Clinical Hospital, Zaragoza, Aragón, Spain
Aragon Health Sciences Institute, Zaragoza, Aragón, Spain.
BMJ Open. 2020 Oct 27;10(10):e040316. doi: 10.1136/bmjopen-2020-040316.
The evidence currently available from enhanced recovery after surgery (ERAS) programmes concerns their benefits in the immediate postoperative period, but there is still very little evidence as to whether their correct implementation benefits patients in the long term. The working hypothesis here is that, due to the lower response to surgical aggression and lower rates of postoperative complications, ERAS protocols can reduce colorectal cancer-related mortality. The main objective of this study is to analyse the impact of an ERAS programme for colorectal cancer on 5-year survival. As secondary objectives, we propose to analyse the weight of each of the predefined items in the oncological results as well as the quality of life.
A multicentre prospective cohort study was conducted in patients older than 18 years of age who are scheduled to undergo surgery for colorectal cancer. The study involved 12 hospitals with an implemented enhanced recovery protocol according to the guidelines published by the Spanish National Health Service. The intervention group includes patients with a minimum implementation level of 70%, and the control group includes those who fail to reach this level. Compliance will be studied using 18 key performance indicators, and the results will be analysed using cancer survival indicators, including overall survival, cancer-specific survival and relapse-free survival. The time to recurrence, perioperative morbidity and mortality, hospital stay and quality of life will also be studied, the latter using the validated EuroQol Five questionnaire. The propensity index method will be used to create comparable treatment and control groups, and a multivariate regression will be used to study each variable. The Kaplan-Meier estimator will be used to estimate survival and the log-rank test to make comparisons. A p value of less than 0.05 (two-tailed) will be considered to be significant.
Ethical approval for this study was obtained from the Aragon Ethical Committee (C.P.-C.I. PI20/086) on 4 March 2020. The findings of this study will be submitted to peer-reviewed journals (, ). Abstracts will be submitted to relevant national and international meetings.
NCT04305314.
目前，关于术后加速康复（ERAS）方案的证据仅涉及其在术后即刻的获益，但关于其正确实施是否能使患者长期获益，证据仍非常有限。本研究的工作假说为，由于对手术侵袭的反应较低以及术后并发症发生率较低，ERAS 方案可降低结直肠癌相关死亡率。本研究的主要目的是分析结直肠癌患者 ERAS 方案对 5 年生存率的影响。次要目标是分析每个预设项目在肿瘤学结果中的权重以及生活质量。
这是一项多中心前瞻性队列研究，纳入了年龄大于 18 岁、拟接受结直肠癌手术的患者。该研究纳入了 12 家实施了根据西班牙国家卫生系统发布的指南制定的强化康复方案的医院。干预组包括实施水平至少达到 70%的患者，对照组包括未达到该水平的患者。使用 18 个关键绩效指标来研究依从性，并使用癌症生存指标分析结果，包括总生存、癌症特异性生存和无复发生存。还将研究复发时间、围手术期发病率和死亡率、住院时间和生活质量，生活质量使用经验证的 EuroQol Five 问卷进行评估。将使用倾向指数法创建可比的治疗组和对照组，并使用多变量回归研究每个变量。使用 Kaplan-Meier 估计器估计生存情况，并使用对数秩检验进行比较。p 值小于 0.05（双侧）被认为具有统计学意义。
本研究于 2020 年 3 月 4 日获得了阿拉贡伦理委员会（C.P.-C.I. PI20/086）的伦理批准。本研究的结果将提交给同行评议期刊（，）。摘要将提交给相关的国内和国际会议。
NCT04305314。
