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多模式术前康复对减少结直肠癌手术后并发症和增强功能能力的影响:PREHAB 随机临床试验。

Effect of Multimodal Prehabilitation on Reducing Postoperative Complications and Enhancing Functional Capacity Following Colorectal Cancer Surgery: The PREHAB Randomized Clinical Trial.

机构信息

Department of Surgery, Máxima Medical Center, Veldhoven, the Netherlands.

Department of Anesthesia, Montreal General Hospital, McGill University Health Center, Montreal, Quebec, Canada.

出版信息

JAMA Surg. 2023 Jun 1;158(6):572-581. doi: 10.1001/jamasurg.2023.0198.

Abstract

IMPORTANCE

Colorectal surgery is associated with substantial morbidity rates and a lowered functional capacity. Optimization of the patient's condition in the weeks prior to surgery may attenuate these unfavorable sequelae.

OBJECTIVE

To determine whether multimodal prehabilitation before colorectal cancer surgery can reduce postoperative complications and enhance functional recovery.

DESIGN, SETTING, AND PARTICIPANTS: The PREHAB randomized clinical trial was an international, multicenter trial conducted in teaching hospitals with implemented enhanced recovery after surgery programs. Adult patients with nonmetastasized colorectal cancer were assessed for eligibility and randomized to either prehabilitation or standard care. Both arms received standard perioperative care. Patients were enrolled from June 2017 to December 2020, and follow-up was completed in December 2021. However, this trial was prematurely stopped due to the COVID-19 pandemic.

INTERVENTIONS

The 4-week in-hospital supervised multimodal prehabilitation program consisted of a high-intensity exercise program 3 times per week, a nutritional intervention, psychological support, and a smoking cessation program when needed.

MAIN OUTCOMES AND MEASURES

Comprehensive Complication Index (CCI) score, number of patients with CCI score more than 20, and improved walking capacity expressed as the 6-minute walking distance 4 weeks postoperatively.

RESULTS

In the intention-to-treat population of 251 participants (median [IQR] age, 69 [60-76] years; 138 [55%] male), 206 (82%) had tumors located in the colon and 234 (93%) underwent laparoscopic- or robotic-assisted surgery. The number of severe complications (CCI score >20) was significantly lower favoring prehabilitation compared with standard care (21 of 123 [17.1%] vs 38 of 128 [29.7%]; odds ratio, 0.47 [95% CI, 0.26-0.87]; P = .02). Participants in prehabilitation encountered fewer medical complications (eg, respiratory) compared with participants receiving standard care (19 of 123 [15.4%] vs 35 of 128 [27.3%]; odds ratio, 0.48 [95% CI, 0.26-0.89]; P = .02). Four weeks after surgery, 6-minute walking distance did not differ significantly between groups when compared with baseline (mean difference prehabilitation vs standard care 15.6 m [95% CI, -1.4 to 32.6]; P = .07). Secondary parameters of functional capacity in the postoperative period generally favored prehabilitation compared with standard care.

CONCLUSIONS AND RELEVANCE

This PREHAB trial demonstrates the benefit of a multimodal prehabilitation program before colorectal cancer surgery as reflected by fewer severe and medical complications postoperatively and an optimized postoperative recovery compared with standard care.

TRIAL REGISTRATION

trialregister.nl Identifier: NTR5947.

摘要

重要性

结直肠手术与较高的发病率和降低的功能能力有关。在手术前的几周内优化患者的状况,可能会减轻这些不良后果。

目的

确定结直肠癌手术前的多模式预康复是否可以减少术后并发症并增强功能恢复。

设计、地点和参与者:PREHAB 随机临床试验是一项在有实施术后恢复增强计划的教学医院进行的国际多中心试验。非转移性结直肠癌患者进行资格评估,并随机分配至预康复或标准护理组。两组均接受标准围手术期护理。患者于 2017 年 6 月至 2020 年 12 月入组,并于 2021 年 12 月完成随访。然而,由于 COVID-19 大流行,该试验提前停止。

干预措施

为期 4 周的住院监督多模式预康复计划包括每周 3 次高强度运动计划、营养干预、心理支持和需要时的戒烟计划。

主要结果和测量指标

综合并发症指数(CCI)评分、CCI 评分大于 20 的患者人数以及术后 4 周时行走能力的改善(6 分钟步行距离)。

结果

在意向治疗人群的 251 名参与者中(中位数[IQR]年龄,69[60-76]岁;138[55%]为男性),206 名(82%)有肿瘤位于结肠,234 名(93%)接受腹腔镜或机器人辅助手术。与标准护理相比,预康复组严重并发症(CCI 评分>20)的数量明显减少(123 例中有 21 例[17.1%] vs 128 例中有 38 例[29.7%];比值比,0.47[95%CI,0.26-0.87];P=0.02)。与接受标准护理的患者相比,预康复组的患者遇到的医疗并发症(如呼吸)更少(123 例中有 19 例[15.4%] vs 128 例中有 35 例[27.3%];比值比,0.48[95%CI,0.26-0.89];P=0.02)。与基线相比,手术后 4 周时两组的 6 分钟步行距离无显著差异(预康复组与标准护理组的平均差异为 15.6 米[95%CI,-1.4 至 32.6];P=0.07)。与标准护理相比,术后期间功能能力的次要参数通常更倾向于预康复。

结论和相关性

这项 PREHAB 试验表明,结直肠癌手术前的多模式预康复计划具有益处,表现在术后严重和医疗并发症减少,与标准护理相比,术后恢复得到优化。

试验注册

NTR5947,trialregister.nl 标识符。

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