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Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation

机译:结肠直肠癌患者的多模式初期,提高功能能力,减少术后并发症:多式联初级国际随机对照试验

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摘要

Abstract Background Colorectal cancer (CRC) is the second most prevalent type of cancer in the world. Surgery is the only curative option. However, postoperative complications occur in up to 50% of patients and are associated with higher morbidity and mortality rates, lower health related quality of life (HRQoL) and increased expenditure in health care. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Traditional approaches have targeted the postoperative period for rehabilitation and lifestyle changes. However, recent evidence shows that the preoperative period might be the optimal moment for intervention. This study will determine the impact of multimodal prehabilitation on patients’ functional capacity and postoperative complications. Methods/design This international multicenter, prospective, randomized controlled trial will include 714 patients undergoing colorectal surgery for cancer. Patients will be allocated to the intervention group, which will receive 4 weeks of prehabilitation (group 1, prehab), or the control group, which will receive no prehabilitation (group 2, no prehab). Both groups will receive perioperative care in accordance with the enhanced recovery after surgery (ERAS) guidelines. The primary outcomes for measurement will be functional capacity (as assessed using the six-minute walk test (6MWT)) and postoperative status determined with the Comprehensive Complication Index (CCI). Secondary outcomes will include HRQoL, length of hospital stay (LOS) and a cost-effectiveness analysis. Discussion Multimodal prehabilitation is expected to enhance patients’ functional capacity and to reduce postoperative complications. It may therefore result in increased survival and improved HRQoL. This is the first international multicenter study investigating multimodal prehabilitation for patients undergoing colorectal surgery for cancer. Trial registration Trial Registry: NTR5947 – date of registration: 1 August 2016.
机译:抽象背景结直肠癌(CRC)是世界上最普遍的癌症类型。手术是唯一的治疗选择。然而,术后并发症患者的50%患者发生,与较高的发病率和死亡率,较低的健康生活质量(HRQOL)和卫生保健支出增加有关。并发症的数量和严重程度与术前功能能力,营养状态,心理状态和吸烟行为密切相关。传统方法针对康复和生活方式的术后期限。然而,最近的证据表明,术前期可能是干预的最佳时刻。本研究将决定多式化效率对患者功能能力和术后并发症的影响。方法/设计这一国际多中心,前瞻性,随机对照试验将包括714名接受癌症的结直肠手术患者。患者将分配给干预组,该干预组将获得4周的初期(第1组,预哈布)或对照组,这不会收到任何职位(第2组,没有预先)。两组将根据手术后的增强恢复(ERAS)指导方针接受围手术期。测量的主要结果将是功能能力(根据使用六分钟的步行测试(6MWT))和术后状态,并通过综合并发症指数(CCI)确定。二次结果将包括HRQOL,住院时间长度(LOS)和成本效益分析。讨论多式联运初期预计将提高患者的功能能力,并减少术后并发症。因此,它可能导致生存增加和改善的HRQOL。这是第一个调查癌症患者患者的多媒体缺乏的国际多元研究。试用登记试验登记处:NTR5947 - 注册日期:2016年8月1日。

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