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Prehabilitation for Elective Major Abdominal Surgery

Not Applicable
Terminated
Conditions
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
Inclusion Criteria

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
Exclusion Criteria
  • 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
Primary Outcome Measures
NameTimeMethod
Postoperative morbidityUp to 30 postoperative days

Comprehensive Complication Index (CCI)

Secondary Outcome Measures
NameTimeMethod
Postoperative most severe complicationUp to 30 postoperative days

Clavien classification

Length of stayUp to 30 postoperative days

From the day of hospitalization to the exit

Readmission ratesUp to 30 postoperative days

Any readmission to the hospital

Exercise capacityAt 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively

Time up and go test

Life satisfactionAt 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 responseUp to 3 postoperative days

C-reactiv protein (CRP) measure

Walking capacityAt 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively

6 minutes Walking Test

HappinessAt 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively

Specific questionnaire (EMMBEP questionnaire)

Nutritional responseUp to 3 postoperative days

Albumin measure

Trial Locations

Locations (1)

Department of Visceral Surgery, University Hospital Center

🇨🇭

Lausanne, Switzerland

Department of Visceral Surgery, University Hospital Center
🇨🇭Lausanne, Switzerland

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