Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

May 17, 2013 updated by: Raj Padwal, University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Raj Padwal, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #B-120208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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