Prehabilitation for Elective Major Abdominal Surgery

Prehabilitation Clinical Trial

— PISO  

Official title:

Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02953119
• Other study ID #: 469/15
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Prehabilitation

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