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OpenTrials
Completed

NCT Number: NCT00850356

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 25, 2009
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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