Prehabilitation for Elective Major Abdominal Surgery
- Conditions
- Prehabilitation
- Interventions
- Other: Prehabilitation
- Registration Number
- NCT02953119
- Lead Sponsor
- Nicolas DEMARTINES
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation Prehabilitation The patients will undergo an exercise test on a cycle ergometer (VO2 max), a grip strength test (Jamar dynamometer), a Time Up and Go (TUG) test and a 6 Minutes Walking Test (6-MWT), before and after prehabilitation. Intervention involves 3 training sessions per week during 3 weeks preoperatively, according to the high intensity interval training model, wich consists of: * 5 minute warm-up (50% of Cardiopulmonary exercise testing, CPET) * Two 10 minute series of 15 sec sprint intervals (100%) interspersed by 15 sec pauses and a 4 min rest between the two series * Cool down with a 5 min active recovery period (30%) The grip strength test (Jamar dynamometer), TUG-test and 6-MWT will be repeated between 4 and 6 weeks and 8 and 10 week postoperatively.
- Primary Outcome Measures
Name Time Method Postoperative morbidity Up to 30 postoperative days Comprehensive Complication Index (CCI)
- Secondary Outcome Measures
Name Time Method Postoperative most severe complication Up to 30 postoperative days Clavien classification
Length of stay Up to 30 postoperative days From the day of hospitalization to the exit
Readmission rates Up to 30 postoperative days Any readmission to the hospital
Exercise capacity At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively Time up and go test
Life satisfaction At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively Specific questionnaire (EORTC:European Organisation for Research and Treatment of Cancer)
Biological inflammatory response Up to 3 postoperative days C-reactiv protein (CRP) measure
Walking capacity At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively 6 minutes Walking Test
Happiness At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively Specific questionnaire (EMMBEP questionnaire)
Nutritional response Up to 3 postoperative days Albumin measure
Trial Locations
- Locations (1)
Department of Visceral Surgery, University Hospital Center
🇨🇭Lausanne, Switzerland