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Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

2013年5月17日 更新者: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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

观察性的

注册 (实际的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alberta
      • Edmonton、Alberta、加拿大、T5H 3V9
        • Royal Alexandra Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
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)
大体时间: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)

次要结果测量

结果测量
大体时间
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.
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Raj Padwal, MD、University of Alberta

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年11月1日

初级完成 (实际的)

2012年8月1日

研究完成 (实际的)

2012年8月1日

研究注册日期

首次提交

2009年2月24日

首先提交符合 QC 标准的

2009年2月24日

首次发布 (估计)

2009年2月25日

研究记录更新

最后更新发布 (估计)

2013年5月21日

上次提交的符合 QC 标准的更新

2013年5月17日

最后验证

2013年5月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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