Clinical trial NCT00283972: LAP-BAND Observational Cohort
Official title: Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epworth Sleepiness Scale
Glycemic Control
Liver Function
Inflammation
Iron and Bone Turnover
SF-36
IW-QOL Lite HRQoL
Keywords: Health Outcome Study
Lead sponsor: Inamed
Sponsor class: INDUSTRY
Collaborators: name: Massachusetts Veterans Epidemiology Research and Information Center
First posted: 2006-01-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous bariatric surgery
* Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts Veterans Epidemiology Research adn Information Center
name: Daniel Deykin, MD
role: STUDY_CHAIR
affiliation: Massachusetts Veterans Epidemiology Research and Information Center
name: Louis Fiore, MD
role: PRINCIPAL_INVESTIGATOR
References: