Department of Clinical Physical Therapy, VieCuri Medical Centre, Venlo, the Netherlands; Department of Epidemiology, GROW Institute for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands.
Adelante Rehabilitation Centre, Venlo, the Netherlands; Department of Rehabilitation Medicine, Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.
Eur J Surg Oncol. 2024 Dec;50(12):108708. doi: 10.1016/j.ejso.2024.108708. Epub 2024 Sep 28.
Current evidence synthesis of prehabilitation studies in colorectal surgery is based on results of randomized controlled trials (RCT). Although RCTs are the gold standard for effectiveness research, observational studies probably better reflect real-life practice. The aims of the current study were to compare observational studies to RCTs regarding the association between prehabilitation and postoperative outcomes, and characteristics of included patients and interventions.
A systematic search was conducted in PubMed, Embase, and CINAHL (until September 2023). Observational studies and RCTs investigating prehabilitation before colorectal surgery and reporting postoperative complications and/or length of stay (LoS) were included. Two reviewers independently assessed the risk of bias using the Cochrane Risk of Bias 2 tool for RCTs and the Cochrane ROBINS-I tool for observational studies. Meta(regression)-analyses were performed for postoperative complications and LoS.
Pooled results showed a statistically significant reduction in postoperative complications (OR 0.54; 95 % confidence interval (CI) 0.40 to 0.72) and LoS (mean difference (MD) -1.34 CI -2.57 to -0.12) after prehabilitation in observational studies but not in RCTs (complications OR 0.95; CI 0.53 to 1.72; LoS MD 0.16 CI -0.52 to 0.83). Patients included in observational studies were older and more often had an ASA score ≥3. In a meta-regression analysis, these characteristics were not statistically significantly associated with the main outcomes.
Observational studies in a real-life setting showed that prehabilitation can reduce postoperative complications and LoS. To further explore the real-life effectiveness of prehabilitation, specific observational study designs, like a target emulation trial could be used.
目前,结直肠外科术前康复研究的证据综合是基于随机对照试验(RCT)的结果。尽管 RCT 是有效性研究的金标准,但观察性研究可能更能反映实际情况。本研究的目的是比较观察性研究和 RCT 之间关于术前康复与术后结果的关系,以及纳入患者和干预措施的特点。
系统检索 PubMed、Embase 和 CINAHL(截至 2023 年 9 月)。纳入研究结直肠术前进行术前康复并报告术后并发症和/或住院时间(LoS)的观察性研究和 RCT。两名审查员使用 Cochrane 风险偏倚 2 工具评估 RCT 的风险偏倚,使用 Cochrane ROBINS-I 工具评估观察性研究的风险偏倚。对术后并发症和 LoS 进行 Meta(回归)分析。
汇总结果显示,在观察性研究中,术前康复后术后并发症(OR 0.54;95%置信区间(CI)0.40 至 0.72)和 LoS(平均差值(MD)-1.34 CI-2.57 至-0.12)有统计学意义的降低,但在 RCT 中则没有(并发症 OR 0.95;CI 0.53 至 1.72;LoS MD 0.16 CI-0.52 至 0.83)。纳入观察性研究的患者年龄较大,且更多的患者 ASA 评分≥3。在一项 Meta 回归分析中,这些特征与主要结局没有统计学显著相关性。
真实环境下的观察性研究表明,术前康复可以减少术后并发症和 LoS。为了进一步探索术前康复的实际效果,可以使用特定的观察性研究设计,如目标仿真试验。