Quality of Life Outcomes and Economic Impacts of Bariatric Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00850356|
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : May 21, 2013
|Condition or disease|
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 reduces weight and the risk of death, decreases obesity-related health problems and increases quality of life. However, surgery carries a 0.5-2% up-front risk of death, has potentially serious short and long-term complications, and an uncertain cost-to-benefit ratio. Surgery is becoming increasingly popular, programs are being initiated or expanded across the country, and waiting lists are several years long. Provincial governments, unable to keep pace with surgical demand, are sending patients to the US for surgery and patients are petitioning governments for increased access to care.
By collecting data from a clinical obesity program that services an entire Canadian health region of over 1 million people and linking these data to provincial and regional data sources, this study aims to:
- Determine whether surgery improves 2-yr medical and patient-centered outcomes (such as quality of life, satisfaction, and others) compared to both medical and community wait-list control patients;
- Comprehensively compare the 3-yr costs of surgical and non-surgical care;
- Determine the impact of 2-yr wait times for surgery on patient health and wellness, including quality of life and patient satisfaction.
This study will provide essential data to accurately determine the benefits, risks, and costs of bariatric surgery in the Canadian context for patients, care providers, and decision makers. Equally important, it will determine whether the health and quality of life of Canadians waiting for surgery is adversely affected because of extended wait-times. Results will directly influence and streamline patient care, will be applicable to similar programs across the country, and serve as an important foundation for future research and data collection.
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||Alberta Population-based, Prospective Evaluation of the Quality of Life Outcomes and Economic Impacts of Bariatric Surgery|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Bariatric Surgery Patient (Sx)
Participants who are patients in an Adult Weight Management Clinic (AWMC) and undergo bariatric surgery.
Medical Treamtent (Mx)
Participants who are patients in the same AWMC as above and are currently undergoing a medical treatment program that includes intensive lifestyle counseling (diets, exercise, behavioral modification).
Participants who are on the Wait-List for the AWMC, and waiting to undergo medical treatment program and/or bariatric surgery.
- Quality of life measured through responses to standardized health questionnaires: SF-12; EQ-5D; IWQoL(Impact of Weight on Quality of Life); PSS(Patient satisfaction survey); Mod WLIQ:(Modified Waiting-list impact questionnaire) [ Time Frame: Every Six months for 2 years (At time =0, 6, 12, 18, 24 months) ]
- Comprehensive comparison of the 3-yr costs of surgical and non-surgical care through medication logs, a questionnaire package, and accessing Alberta health and Wellness data. [ Time Frame: Every six months for 2 years (At time =0, 6, 12, 18, 24 months) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850356
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|
|Principal Investigator:||Raj Padwal, MD||University of Alberta|