Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
研究概览
简要总结
To prospectively observe the association of the LAP-BAND procedure on quality of life, anthropometric, metabolic and biochemical parameters in morbidly obese patients when performed by experienced US surgeons. The study will also include a complete economic analysis of the LAP-BAND procedure and follow-up costs Hypothesis: Measurements defining quality of life and the severity of obesity and obesity related comorbidities improve significantly over baseline with the LAP-BAND System treatment at 6 and 12 months post surgery when performed by an experienced surgeon.
详细描述
Study Type: Observational cohort. Single arm (non-comparative), non-randomized, multi-site surgical case series.
Objective
To prospectively observe the association of the LAP-BAND System device on measurements of quality of life, anthropometric, metabolic and biochemical parameters in morbidly obese patients when performed by experienced U.S. surgeons. Cost effectiveness analysis will also be done.
Numbers: This study will enroll 240 patients total from six U.S. bariatric surgical practices
Duration: Individual subject participation will be approximately 15 months. Data will be collected at a baseline less than three months prior to surgery or before starting a Very Low Calorie Diet (VLCD), then at 6 and 12 months post surgery. The total duration, including enrollment, of the observational period for the cohort is expected to be 21 months. Subjects have the option to consent for future contact by investigators for a period of 10 years following their surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbid Obesity: BMI >40 kg/m2 or
- •BMI > or equal to 35 kg/m2 with significant obesity related comorbidity
- •Age 18 years old or older
- •Dietary attempts at weight control have been ineffective
- •Consented for surgery with LAP-BAND System by pre qualified bariatric surgeon
- •Willingness and ability to follow protocol requirements
- •Residing within a reasonable distance from the surgeon's office and being able to travel to the surgeon's office to complete all routine follow-up visits
排除标准
- •Previous bariatric surgery
- •Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons