Lap-Band Surgery on Adolescents for Safety and Efficacy (ALAGB)

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)

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

Study Overview

• Status: Completed
• Conditions: Obesity; DM
• Intervention / Treatment: Device: Lap-Band

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

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Hope Foundation
• Investigators: Principal Investigator: Christine Ren-Fielding, M.D., NYUSOM

Publications and helpful links

Helpful Links

• NYU Program for Surgical Weight Loss

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): July 8, 2020
• Study Completion (Actual): July 8, 2020

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Child Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 11876; G050010 (Other Identifier: H 11876)