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临床试验/NCT06443203
NCT06443203进行中(未招募)不适用

A Randomized Controlled Clinical Trial on Multimodal Prehabilitation in Colorectal Cancer Patients to Improve Functional Capacity and Lower Postoperative Complications.

University Hospital of Ferrara2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
112
试验地点
2
主要终点
Postoperative functional capacity

研究概览

简要总结

Postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. Even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. Many of these negative effects can be decreased by applying specific ERAS (Enhanced Recovery After Surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients' post-operative convalescence and facilitate their return to functional activities.

In this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.

详细描述

This study aims to determine the effect of prehabilitation on patients' functional capacity and postoperative complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation (N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS) guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients of age >18 years;
  • elective colorectal resection for colonic cancer.

排除标准

  • metastatic disease;
  • severe walking impairments;
  • renal failure stage >2;
  • ASA score >3;
  • preoperative chemo-radiation therapy.

结局指标

主要结局

Postoperative functional capacity

时间窗: From enrollment to the end of treatment at 8 weeks after surgery

The primary outcome for functional capacity was measured by the 6-Minute Walking Test (6MWT), chosen as a validated, objective measure of colorectal surgery recovery integrating all components of physical activity.

次要结局

  • Hospital length of stay(Within 30 days after surgery)
  • Post-operative complications(Within 30 days after surgery)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Feo

Principal Investigator

University Hospital of Ferrara

研究点 (2)

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