Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alberta Population-based, Prospective Evaluation of the Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

Conditions
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Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bariatric Surgery Patient (Sx)<br>Participants who are patients in an Adult Weight Management Clinic (AWMC) and undergo bariatric surgery. | |
| Medical Treamtent (Mx)<br>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). | |
| Wait-List (Wx)<br>Participants who are on the Wait-List for the AWMC, and waiting to undergo medical treatment program and/or bariatric surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Every Six months for 2 years (At time =0, 6, 12, 18, 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Every six months for 2 years (At time =0, 6, 12, 18, 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery, Body Weight, Health care costs, Obesity, Obesity Complications, Prolonged wait times, Quality of Life