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Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

17 maj 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Tidsram
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.
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Raj Padwal, MD, University of Alberta

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2008

Primärt slutförande (Faktisk)

1 augusti 2012

Avslutad studie (Faktisk)

1 augusti 2012

Studieregistreringsdatum

Först inskickad

24 februari 2009

Först inskickad som uppfyllde QC-kriterierna

24 februari 2009

Första postat (Uppskatta)

25 februari 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

21 maj 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 maj 2013

Senast verifierad

1 maj 2013

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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