Laparoscopic Adjustable Gastric Banding in Adolescents

Kirk Reichard

Status: Completed

Conditions: Morbid Obesity

Treatments: Device: Adjustable Gastric Band

Study type: Interventional

Funder types: Other

Identifiers

NCT01619488

0082295

Details and patient eligibility

About

This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.

Full description

This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents

Enrollment: 57 patients

Sex: All

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ages 14-19
• BMI > 35
• history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
• confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.

Exclusion criteria

• history of congenital or acquired anomalies of the GI tract.
• history of esophageal motility disorders
• uncontrolled psychiatric problems
• previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
• uncontrolled eating disorders

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Gastric Banding

Experimental group

Description:

Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.

Treatment:

Device: Adjustable Gastric Band