Inflammation Clinical Trial
Official title:
Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
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.
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.
;
Observational Model: Defined Population, Time Perspective: Longitudinal
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