- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00227526
Enhancing Outcomes After Colon Surgery
Enhancing Outcomes After Colon Surgery: Role of Prehabilitation Facilitating the Recovery Process.
Study Overview
Detailed Description
The surgical process is a major stressor because of the psychological distress, tissue trauma, lack of activity, and quasi-starvation and it produces immediate systemic changes and both short- and long-term effects on activity and quality of life. However, there is mounting evidence that many of the negative immediate effects of surgery such as pain, fatigue, and weakness are amenable to intervention. If proper interventions are carried out, these symptoms may be readily controlled allowing for a faster recovery and early home discharge. But the effects of surgery are felt far beyond the immediate convalescent period and patients can feel fatigued for many weeks and this delays return to usual function and reduces quality of life. Thus, it would be of great practical benefit if ways of improving post-surgery physical function and quality of life could be identified.
Traditionally efforts have been made to improve the recovery process by intervening in the post-operative period. However, the post-operative period may not be the most opportune time to introduce interventions to accelerate recovery. Many of these surgical patients are concerned about perturbing the healing process as well as being depressed and anxious if they await further treatment. The pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual to enable him or her to withstand an incoming stressor has been termed prehabilitation The purpose of this study is to address the following research question: Among persons scheduled for colorectal surgery, does a pre-operative program of aerobic and muscle strength training (prehabilitation) compared to a standard peri-operative educational protocol affect functional exercise capacity and health-related quality of life? The trial will be a single blind, stratified (on cancer diagnosis or not), randomized, two-group (prehabilitation or standard care), parallel design. Both groups will receive the same peri-operative education program. In conformity with current practice, all subjects will also be advised on nutritional support during the preoperative period. Persons with albumin < 38 gm./l will receive an adequate supply of protein and calorie nutritional supplement bars. In addition to this standard care, the prehabilitation group will be prescribed a program of exercise training consisting of daily stationary cycling from the start of the intervention to the day prior to surgery (minimum 3 weeks) combined with an individualized program of muscle strength training.
Both groups will be evaluated for exercise tolerance, walking capacity and health and emotional status at enrolment and after 3 three weeks of training as well as at 4 weeks, 8 weeks and 24 weeks (6 months) post-surgery. The main outcome measure will be the 6 Minute Walk Test - a valid and reliable measure of functional walking capacity. The estimator of effect will be the proportion of people in each group who, at 8 weeks post-surgery, achieve or exceed their baseline value on this test (± 20m). The proposed sample size is 200. This is based on 80% power to detect a difference of 22% in the proportion recovering to baseline values (40% in standard and 62% in prehabilitation). The results of this trial will be used to inform practitioners and patients alike of the benefits (or risks if any) of exercise in preparing for surgery.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 and above
- Referred electively for colorectal resection for benign (polyposis adenoma diverticulitis) or non-disseminated colon and rectum cancers
- Referred electively for colorectal resection for colon reconstruction for non-active inflammatory bowel disease
- Referred electively for colorectal resection for fibrostenotic conditions that are a feature of Crohn's disease.
Exclusion Criteria:
- People with American Society of Anesthesiologists health status class 4-5
- Co-morbid medical conditions interfering with the ability to participate in either group or complete the testing procedures (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
- Patients at high risk for a cardiac complication during exercise at home: severe aortic stenosis, cardiac failure Class IV NYHA, myocardial infarction within 6 months, congestive heart failure, and unstable angina
- Persons with sepsis; and treatment with chemotherapy or radiotherapy during six months prior to the date of surgery
- Those with very low exercise tolerance (<3.5 METS) as determined by the baseline exercise test
- Anyone with a cardiac arrhythmia that manifests during the baseline exercise testing, prior to randomization
- Those people who are already in excellent physical condition owing to a regular participation in a high intensity physical activity. On testing, persons whose age-predicted value on the 6MWT exceeds 130% will be excluded (expected <10%)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
6 Minute Walk Test
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
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baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
V02 max and submax
Time Frame: baseline, 24 weeks
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baseline, 24 weeks
|
SF-36 - Short form 36
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
CHAMPS - Community Healthy Activities Model Program for Seniors
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
Hospital Anxiety Depression Scale - HADS
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
Fatigue and Pain VAS
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
Visual Analogue Mood States (VAMS)
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
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baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
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2Minute Walk Test
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
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baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
Complications: infection (wound, sepsis, urinary, lung); bleeding; wound dehiscence; technical complications (ileus, anastomotic leakage); stroke, MI, DVT/PE, delirium, fall w/wo injury; malnutrition; urinary retention; respiratory failure
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
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Charges for bed day: surgical procedure; surgeon/anaesthesiologist; pre, post and follow-up tests and procedures; visits; follow-up medications
Time Frame: baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
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baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Carli F, Mayo N. Measuring the outcome of surgical procedures: what are the challenges? Br J Anaesth. 2001 Oct;87(4):531-3. doi: 10.1093/bja/87.4.531. No abstract available.
- Carli F. Perioperative factors influencing surgical morbidity: what the anesthesiologist needs to know. Can J Anaesth. 1999 May;46(5 Pt 2):R70-9. doi: 10.1007/BF03013183. No abstract available. English, French.
- Carli F, Mayo N, Klubien K, Schricker T, Trudel J, Belliveau P. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002 Sep;97(3):540-9. doi: 10.1097/00000542-200209000-00005.
- Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
- Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC02-053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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