Clinical trial NCT00587301: Lap-Band Surgery on Adolescents for Safety and Efficacy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
DM
Keywords: Child Obesity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Hope Foundation
First posted: 2008-01-07
Enrollment: 119
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Excess Weight Loss (EWL)
timeFrame: Year 1
measure: Percentage of Excess Weight Loss (EWL)
timeFrame: Year 2
measure: Percentage of Excess Weight Loss (EWL)
timeFrame: Year 3
measure: Percentage of Excess Weight Loss (EWL)
timeFrame: Year 4
measure: Percentage of Excess Weight Loss (EWL)
timeFrame: Year 5
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Year 1
measure: Body Mass Index (BMI)
timeFrame: Year 2
measure: Body Mass Index (BMI)
timeFrame: Year 3
measure: Body Mass Index (BMI)
timeFrame: Year 4
measure: Body Mass Index (BMI)
timeFrame: Year 5
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYUSOM
name: Christine Ren-Fielding, M.D.
role: PRINCIPAL_INVESTIGATOR
References: