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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02953119
Other study ID # 469/15
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date April 2020

Study information

Verified date June 2020
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 20
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Prehabilitation


Locations

Country Name City State
Switzerland Department of Visceral Surgery, University Hospital Center Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Nicolas DEMARTINES

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative morbidity Comprehensive Complication Index (CCI) Up to 30 postoperative days
Secondary Postoperative most severe complication Clavien classification Up to 30 postoperative days
Secondary Length of stay From the day of hospitalization to the exit Up to 30 postoperative days
Secondary Readmission rates Any readmission to the hospital Up to 30 postoperative days
Secondary Exercise capacity Exercise testing on a cycloergometer(VO2 max) At 3 and 1 week preoperatively
Secondary Life satisfaction Specific questionnaire (EORTC:European Organisation for Research and Treatment of Cancer) At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Secondary Biological inflammatory response C-reactiv protein (CRP) measure Up to 3 postoperative days
Secondary Exercise capacity Time up and go test At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Secondary Walking capacity 6 minutes Walking Test At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Secondary Happiness Specific questionnaire (EMMBEP questionnaire) At 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively
Secondary Nutritional response Albumin measure Up to 3 postoperative days
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