Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Postoperative morbidity
研究概览
简要总结
Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery.
The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.
详细描述
Major abdominal surgery is a great stressor to patients and causes large physiological changes, leads to tissue trauma, immobility, psychological distress and reduced quality of life. Physical capacity appears to be an important predictor for postoperative recovery after major abdominal surgery. Prehabilitation is a concept that challenges the traditional models of recovery by initiating the recovery process preoperatively. Improvement of physical capacity by means of prehabilitation may facilitate better recovery after surgery. More specifically prior to major abdominal surgery, preoperative exercise therapy is associated with improved physical fitness of patients, but whether or not this results in fewer complications or faster convalescence remains unclear.
The aim of the present study is to evaluate the impact of preoperative physical exercise training (prehabilitation) on postoperative recovery and clinical outcomes after major abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective major abdominal surgery:
- •Esophagus, stomach
- •Liver, pancreas
- •Small intestine, colon, rectum
- •Benign or malignant disease
- •Other intra-abdominal open or laparoscopic surgery lasting> 2 hours
- •Delay of 3 weeks between consultation and surgery
排除标准
- •Patient < 18 years, consent not obtained
- •Coronary artery disease (≥ stage III according to CCS)
- •Heart disease (≥ stage III according to NYHA)
- •Uncontrolled cardiac arrhythmias
- •COPD (GOLD stage ≥ III)
- •Physical inability to ride a bike
- •Orthopedic surgery in the last 6 weeks
结局指标
主要结局
Postoperative morbidity
时间窗: Up to 30 postoperative days
Comprehensive Complication Index (CCI)
次要结局
- Postoperative most severe complication(Up to 30 postoperative days)
- Length of stay(Up to 30 postoperative days)
- Readmission rates(Up to 30 postoperative days)
- Exercise capacity(At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively)
- Life satisfaction(At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively)
- Biological inflammatory response(Up to 3 postoperative days)
- Walking capacity(At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively)
- Happiness(At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively)
- Nutritional response(Up to 3 postoperative days)
研究者
Nicolas DEMARTINES
Professor
University of Lausanne Hospitals