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Prehabilitation for Elective Major Abdominal Surgery

Prehabilitation for Elective Major Abdominal Surgery: a Randomised Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02953119
Acronym
PISO
Enrollment
20
Registered
2016-11-02
Start date
2016-10-31
Completion date
2020-04-30
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prehabilitation

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.

Interventions

OTHERPrehabilitation

Sponsors

Nicolas DEMARTINES
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative morbidityUp to 30 postoperative daysComprehensive Complication Index (CCI)

Secondary

MeasureTime frameDescription
Length of stayUp to 30 postoperative daysFrom the day of hospitalization to the exit
Readmission ratesUp to 30 postoperative daysAny readmission to the hospital
Exercise capacityAt 3 and 1 week preoperativelyExercise testing on a cycloergometer(VO2 max)
Life satisfactionAt 3 and 1 week preoperatively, then at 4 and 8 weeks postoperativelySpecific questionnaire (EORTC:European Organisation for Research and Treatment of Cancer)
Postoperative most severe complicationUp to 30 postoperative daysClavien classification
Walking capacityAt 3 and 1 week preoperatively, then at 4 and 8 weeks postoperatively6 minutes Walking Test
HappinessAt 3 and 1 week preoperatively, then at 4 and 8 weeks postoperativelySpecific questionnaire (EMMBEP questionnaire)
Nutritional responseUp to 3 postoperative daysAlbumin measure
Biological inflammatory responseUp to 3 postoperative daysC-reactiv protein (CRP) measure

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026