Randomized Controlled Trial Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the ERAS Protocol for the Improvement of Postoperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Comprehensive Complication Index (CCI)
研究概览
简要总结
The purpose of this study is to determine whether a combined cardiorespiratory and strengthening training prior to colorectal surgery decreases the rate of surgery-related complications.
详细描述
This single site study investigates whether a preoperative training reduces the number and severity of perioperative complications in patients undergoing elective colorectal surgery according to the Enhanced Recovery After Surgery (ERAS) pathway.
The study will be approved by a local ethical committee and conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP as well as all national legal and regulatory requirements. Before inclusion informed written consent will be obtained from all patients.
Once the indication for the surgical intervention is given patients may be included into the study. Patients of the experimental group will be provided with a tailored training program aiming at maximally improving physical fitness in order to withstand the surgical stress. Depending on the urgency of the operation this training program will last between two and six weeks. Three weekly trainings are foreseen of which two will be performed in a setting supervised by a physiotherapist and one at the patient's home.
Patients assigned to the control group receive the usual care i.e. information about the upcoming procedure and the advice to remain physically active.
From the point of the operation both groups will be treated equally. Outcome measures will be obtained from the inclusion into the study up to one month after surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years) suffering from colorectal diseases needing an operative treatment and treated along our ERAS pathway
- •Patients suffering from colorectal cancer, diverticulosis, benign tumors such as polyps or inflammatory bowel disease and surgically treated (i.e. rectosigmoid resection, anterior resection of rectum, ileocaecal/right hemicolectomy, left hemicolectomy, abdominoperineal resection or total/subtotal colectomy), and patients undergoing reversal of Stoma and Hartmann procedures will be included.
- •Informed Consent as documented by signature
排除标准
- •Patients suffering from severe dementia or other cognitive impairment, what hinders them to give informed consent
- •Patients with a physical impairment, who can't perform the necessary physical Training
- •Patients, who are not able or willing to attend the physical training at the institute of physiotherapy of the Kantonsspital Winterthur
- •Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Comprehensive Complication Index (CCI)
时间窗: 30 days
ssessment of patients' overall morbidity. CCI is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).
次要结局
- Five Times Sit to Stand Test(30 days)
- 2-Minute Walk Test(30 days)
- Perceived pain(30 days)
- Clavien/Dindo(30 days)