LAP-BAND Observational Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Epworth Sleepiness Scale Glycemic Control Liver Function Inflammation Iron and Bone Turnover SF-36 IW-QOL Lite HRQoL

Keywords

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Health Outcome Study

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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LAP-BAND System

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Daniel Deykin, MD

Role: STUDY_CHAIR

Massachusetts Veterans Epidemiology Research adn Information Center

Louis Fiore, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Veterans Epidemiology Research and Information Center

Other Identifiers

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12242004P

Identifier Type: -

Identifier Source: org_study_id