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Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT00850356
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : May 21, 2013
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Raj Padwal, University of Alberta

Tracking Information
First Submitted Date February 24, 2009
First Posted Date February 25, 2009
Last Update Posted Date May 21, 2013
Study Start Date November 2008
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2009)
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) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00850356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 24, 2009)
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) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life Outcomes and Economic Impacts of Bariatric Surgery
Official Title Alberta Population-based, Prospective Evaluation of the Quality of Life Outcomes and Economic Impacts of Bariatric Surgery
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 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:

  1. 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;
  2. Comprehensively compare the 3-yr costs of surgical and non-surgical care;
  3. 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
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Three participant goups (n=500:)

Bariatric Surgery(Sx):150 participants. Patients approved for bariatric surgery in an Adult Weight Management Clinic (AWMC) will be eligible (BMI ≥35 kg/m2 and a major medical comorbidity or BMI ≥ 40 kg/m2). Contraindications to surgery are pregnancy, unstable psychiatric disease, patients deemed too medically high-risk, age > 60 years, active substance abuse, or an active eating disorder.

Medical Treatment(Mx):200 participants. Patients will be approached for the study upon their first visit in the AWMC.

Both medical and surgical patients receive intensive lifestyle counseling (diets, exercise, behavioral modification) delivered according to current recommendations. Other than receiving extra education about surgery and post-operative diets, there is no difference in care between the medical and surgical arms.

Community Wait-List Control(Wx):150 participants will be enrolled from the list of newly referred patients to the AWMC.

Condition Obesity
Intervention Not Provided
Study Groups/Cohorts
  • 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).
  • Wait-List (Wx)
    Participants who are on the Wait-List for the AWMC, and waiting to undergo medical treatment program and/or bariatric surgery.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 24, 2009)
500
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. 18-60 years old
  2. Male and Female
  3. 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
  4. Able to provide written informed consent

Exclusion Criteria:

  1. Pregnant or nursing
  2. Previously enrolled in this study (e.g Community Control Arm)
  3. Currently participating in a clinical trial
  4. Individual expected to have difficulty with follow-up visits, completion of questionnaires, etc.
  5. Any contraindications to bariatric surgery and/or anti-obesity medical treatment
  6. Ability and willingness to complete questionnaires.
  7. Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol.
  8. Patients in whom protein sparing very low calorie diet therapy is planned.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00850356
Other Study ID Numbers #B-120208
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Raj Padwal, University of Alberta
Study Sponsor University of Alberta
Collaborators Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Raj Padwal, MD University of Alberta
PRS Account University of Alberta
Verification Date May 2013