Colorectal Cancer Clinical Trial
Official title:
Feasibility Study of Preoperative Exercise Intervention in the Resection of Colorectal Liver Metastasis.
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.
Hypothesis
1. A short period of exercise can significantly improve fitness prior to liver surgery
2. Greater Fitness is associated with better liver function.
Status | Completed |
Enrollment | 37 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Planned resection of colorectal liver metastasis - Able to perform cycle based exercise program - Age over 18 Exclusion Criteria: - Unable to consent - Unable to perform cycle based exercise program - Age under 18 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aintree University Hospital | Liverpool | Merseyside |
Lead Sponsor | Collaborator |
---|---|
Aintree University Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anaerobic threshold prior to liver resection | This is a measure of cardiopulmonary fitness as detected by a cardiopulmonary exercise test. | 4 weeks | No |
Secondary | Hospital Length of stay | length of hospital admission from date of surgery | 6 weeks | No |
Secondary | Post operative morbidity | As measured using Clavien classification and postoperative morbidity scores | 3 months | Yes |
Secondary | Quality of Life | SF -36 and EORTC questionaires at 5 weeks, 6 weeks postoperatively, and 3 months postoperatively | 4 months | No |
Secondary | Mortality | 30 day and 90 day postoperative | Yes | |
Secondary | Attendance at exercise sessions | 6 weeks | No | |
Secondary | Serious adverse events within exercise program | The investigators are not expecting and serious adverse events during the program. | 6 weeks | Yes |
Secondary | other measures of cardiopulmonary function | Detected by cardiopulmonary exercise prior to surgery. | 6 weeks | No |
Secondary | Recovery of fitness | recovery of cardiopulmonary exercise test determined fitness post surgery. | 6 and 12 weeks post operatively | No |
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