Prehabilitation in Liver Surgery
|ClinicalTrials.gov Identifier: NCT01523353|
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : December 17, 2013
Each year in the UK around 1500 patients undergo surgery for bowel cancer that has spread to the liver. This is major surgery that offers a chance of cure, but can be associated with complications. Fitter patients are less likely to have serious complications. We are interested in finding out whether a short exercise program can improve patient fitness before surgery and whether this can reduce surgical complications.
We plan to measure the fitness of patients who are going to have liver surgery. We will then give them an exercise programme for 4 weeks, after which we will assess their fitness again.
We are also interested in whether fitter people have better Liver function. To assess this we will take a small sample of liver tissue during the operation for laboratory analysis of its function.
- A short period of exercise can significantly improve fitness prior to liver surgery
- Greater Fitness is associated with better liver function.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Liver Metastasis Liver Surgery Exercise Intervention||Behavioral: Exercise Intervention||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: Exercise Intervention
4 week personalised exercise program on a static bicycle.
Behavioral: Exercise Intervention
4 week personalised exercise program on a static cycle. Supervised in a hospital environment
No Intervention: Control Arm
Patients having standard preoperative preparation and advice.
- Anaerobic threshold prior to liver resection [ Time Frame: 4 weeks ]This is a measure of cardiopulmonary fitness as detected by a cardiopulmonary exercise test.
- Hospital Length of stay [ Time Frame: 6 weeks ]length of hospital admission from date of surgery
- Post operative morbidity [ Time Frame: 3 months ]As measured using Clavien classification and postoperative morbidity scores
- Quality of Life [ Time Frame: 4 months ]SF -36 and EORTC questionaires at 5 weeks, 6 weeks postoperatively, and 3 months postoperatively
- Mortality [ Time Frame: 30 day and 90 day postoperative ]
- Attendance at exercise sessions [ Time Frame: 6 weeks ]
- Serious adverse events within exercise program [ Time Frame: 6 weeks ]The investigators are not expecting and serious adverse events during the program.
- other measures of cardiopulmonary function [ Time Frame: 6 weeks ]Detected by cardiopulmonary exercise prior to surgery.
- Recovery of fitness [ Time Frame: 6 and 12 weeks post operatively ]recovery of cardiopulmonary exercise test determined fitness post surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523353
|Aintree University Hospital|
|Liverpool, Merseyside, United Kingdom, L9 7AL|
|Principal Investigator:||Declan FJ Dunne, MBChB(Hons)||Aintree University Hospitals NHS Foundation Trust|