Status:
COMPLETED
Enhancing Outcomes After Colon Surgery
Lead Sponsor:
McGill University
Collaborating Sponsors:
Canadian Anesthesiologists' Society
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Most patients find that recovering from surgery is difficult particularly after abdominal surgery for cancer or other intestinal disorders. The surgical stress, healing process and concerns if further...
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 lon...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00227526
Start Date
February 1 2005
End Date
December 1 2008
Last Update
September 6 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4