Status:
COMPLETED
Quality of Life Outcomes and Economic Impacts of Bariatric Surgery
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Brief Summary
The purpose is to determine the economic, clinical and quality of life outcomes of bariatric surgery and describe the consequences of protracted wait-times (\~ 2 years) for this procedure.
Detailed Description
Severe obesity affects approximately 3% of Canadians (nearly 1 million people) and is becoming increasingly common and costly. Surgery for severe obesity, known as bariatric surgery, substantially red...
Eligibility Criteria
Inclusion
- 18-60 years old
- Male and Female
- BMI Levels greater than or equal to 35 kg/m2 and a major medical comorbidity OR BMI levels greater than or equal to 40 kg/m2
- Able to provide written informed consent
Exclusion
- Pregnant or nursing
- Previously enrolled in this study (e.g Community Control Arm)
- Currently participating in a clinical trial
- Individual expected to have difficulty with follow-up visits, completion of questionnaires, etc.
- Any contraindications to bariatric surgery and/or anti-obesity medical treatment
- Ability and willingness to complete questionnaires.
- Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
- Patients in whom protein sparing very low calorie diet therapy is planned.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00850356
Start Date
November 1 2008
End Date
August 1 2012
Last Update
May 21 2013
Active Locations (1)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9