Colorectal Neoplasms Clinical Trial
Official title:
An Investigation Into the Role of Cardiopulmonary Exercise Testing and Pre-operative Exercise Training in Patients Undergoing Major Surgery for Colorectal Cancer
NCT number | NCT01924897 |
Other study ID # | 2013ONC11S |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | August 14, 2013 |
Last updated | August 16, 2013 |
Colorectal Surgery Preoperative Exercise Training is a study being run by the colorectal
surgery team at the Norfolk and Norwich University Hospital and the University of East
Anglia to look at the role of exercise before surgery to improve recovery following an
operation.
Having an operation to remove part of the bowel puts physical stress on the body. We know
that training can help the body cope with physical stress in the same way that an athlete
trains before a competition. We hypothesise that the body may recover more quickly if it is
trained prior to an operation with regular and simple exercises.
Cardiopulmonary exercise testing (CPET) is used to evaluate the function of the lungs, heart
and muscles at rest and during exercise. CPET testing is often done as part of standard
pre-operative assessment in many hospitals for patients before undergoing major surgery.
Some studies have demonstrated that CPET can be used to predict outcomes following surgery
(such as time taken till discharge, complication rates).
The study consists of two parts:
Study 1) CPET variables to predict outcomes in surgery - patients will undergo a CPET test
to determine baseline fitness. Blood tests will be taken around the time of surgery to
examine whether biochemical markers in the bloodstream (when used in combination with
results from the CPET test) can predict outcomes and recovery following colorectal surgery.
Patients will then be monitored to assess their speed of recovery and rate of complications
following surgery.
This will enable us to determine which CPET variables or combination of variables are most
useful in the prediction of post-operative complications following colorectal surgery.
2) The second study will consist of an exercise intervention involving several sessions of
supervised exercise in a laboratory. Before and at the end the exercise training regime,
CPET measurements will be taken to see if fitness has improved with exercise.
This part of of the study is to determine if it is feasible to implement a structured,
supervised exercise programme for patients awaiting elective colorectal cancer surgery. The
results of this study will be used to inform a larger randomised controlled trial to examine
the influence of exercise on CPET variables and postoperative outcomes.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Written informed consent 2. Colorectal malignancy suitable for curative resection, no metastatic disease 3. Elective procedure, ability to undergo CPET testing 4. American Society of Anaesthesiologists (ASA) physical status I-III Exclusion Criteria: 1. Emergency surgery 2. Unable to participate due to any of the following absolute contraindications to CPET testing: acute MI in past 3 - 5 days; Unstable angina; Uncontrolled arrhythmias; Syncope; Active endocarditis; Symptomatic severe aortic stenosis; Acute PE; DVT; Uncontrolled asthma; Pulmonary oedema; Room air desaturation at rest <85%; Respiratory failure; Cognitive impairment leading to inability to cooperate 3. Distant metastases on CT 4. American Society of Anaesthesiologists (ASA) physical status IV |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Norfolk and Norwich University Hospital | Norwich | Norfolk |
United Kingdom | University of East Anglia | Norwich | Norfolk |
Lead Sponsor | Collaborator |
---|---|
University of East Anglia | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feasibility outcomes for exercise training | The primary outcomes of this study are to assess the feasibility of conducting this trial on a larger scale: to identify the number of eligible patients, recruitment rate, willingness of patients to be randomised, willingness of clinicians to participate in the trial, compliance/tolerance of the exercise regimen, patient satisfaction with the process and attrition. In addition, the costs of undergoing CPET testing and supervised exercise training will be estimated. An assessment of the characteristics/variability of key health outcomes will also be undertaken, i.e. changes in CPET variables following exercise training, postoperative complications, length of stay, and health-related quality of life benefits, thus enabling identification of a suitable primary outcome measure and sample size calculation for a larger trial. |
30 days following surgery | No |
Primary | postoperative morbidity | Patient notes will be reviewed on each postoperative day to identify incidence of postoperative complications according to the Post-Operative Morbidity Survey system (POMS), a validated 18-item scoring tool which assesses nine domains of morbidity relevant to the post-surgical patient according to precisely defined criteria (pulmonary, infection, renal, gastrointestinal, cardiovascular, wound complications, haematological and pain. | First 30 days following surgery | No |
Secondary | post-operative stay | total postoperative hospital stay (days postop), (including the length of stay for those patients who are readmitted to hospital within 30 days of their surgery), | 30 days | No |
Secondary | mortality | mortality in the first 30 days following surgery will be recorded | 30 days | No |
Secondary | Admission to HDU/ITU | The need for transfer from ward-level care to higher level care (high dependency or intensive care) following surgery | 30 days | No |
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