Lap-Band Surgery on Adolescents for Safety and Efficacy

Study Overview
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Brief Summary
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This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.

Detailed Description
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STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss. STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL). DESIGN:Prospective, open-label, and single center

Official Title
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A Prospective, Open-label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17)

Conditions
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Obesity, DM

Intervention / Treatment
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* Device: Lap-Band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 14 and less than 18 years of age at the time of enrollment into the study. Have a BMI of at least 40 Have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity. Confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol. Express willingness to follow protocol requirements. •Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception. Exclusion Criteria: Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement. History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulopathy; hepatic insufficiency or cirrhosis. Presence of dysphagia or documented esophageal dysmotility. Patients with autoimmune connective tissue disorders Patients with acute abdominal infections Pregnancy or intention of becoming pregnant in the next 12 months. Presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol. History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis. Presence of localized or systemic infection at the time of surgery. Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications. History of gastric or esophageal surgery. Use of weigh loss medications simultaneously

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lap-Band<br>Lap-band surgery in treatment of morbidly obese adolescents | Device: Lap-Band<br>* Obesity and adolescents<br>* Other names: Lap-Band Adjustable Gastric Band (LAGB) Operation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Excess Weight Loss (EWL) |  | Year 1 | 
| Percentage of Excess Weight Loss (EWL) |  | Year 2 | 
| Percentage of Excess Weight Loss (EWL) |  | Year 3 | 
| Percentage of Excess Weight Loss (EWL) |  | Year 4 | 
| Percentage of Excess Weight Loss (EWL) |  | Year 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) |  | Year 1 | 
| Body Mass Index (BMI) |  | Year 2 | 
| Body Mass Index (BMI) |  | Year 3 | 
| Body Mass Index (BMI) |  | Year 4 | 
| Body Mass Index (BMI) |  | Year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child Obesity