LAP-BAND Observational Cohort

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 Overview

• Status: Unknown
• Conditions: Inflammation; Liver Function; Glycemic Control; Epworth Sleepiness Scale; Iron and Bone Turnover; SF-36; IW-QOL Lite HRQoL
• Intervention / Treatment: Device: LAP-BAND System

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.

• Study Type: Observational
• Enrollment: 240

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Inamed
• Collaborators: Massachusetts Veterans Epidemiology Research and Information Center
• Investigators: Study Chair: Daniel Deykin, MD, Massachusetts Veterans Epidemiology Research adn Information Center; Principal Investigator: Louis Fiore, MD, Massachusetts Veterans Epidemiology Research and Information Center

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Study Completion: December 1, 2006

Study Registration Dates

• First Submitted: January 24, 2006
• First Submitted That Met QC Criteria: January 30, 2006
• First Posted (ESTIMATE): January 31, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): January 31, 2006
• Last Update Submitted That Met QC Criteria: January 30, 2006
• Last Verified: January 1, 2006

More Information

Terms related to this study

• Keywords: Health Outcome Study
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Sleepiness
• Other Study ID Numbers: 12242004P