ALAGB: Lap-Band Surgery on Adolescents for Safety and Efficacy

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00587301
• Collaborator: Hope Foundation (Other)
• Enrollment: 119
• Location: 1
• Arm: 1
• Duration (Months): 181.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; DM	Device: Lap-Band	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 119 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2005
• Actual Primary Completion Date: Jul 8, 2020
• Actual Study Completion Date: Jul 8, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Excess Weight Loss (EWL) [Year 1]

2. Percentage of Excess Weight Loss (EWL) [Year 2]

3. Percentage of Excess Weight Loss (EWL) [Year 3]

4. Percentage of Excess Weight Loss (EWL) [Year 4]

5. Percentage of Excess Weight Loss (EWL) [Year 5]

Secondary Outcome Measures

1. Body Mass Index (BMI) [Year 1]

2. Body Mass Index (BMI) [Year 2]

3. Body Mass Index (BMI) [Year 3]

4. Body Mass Index (BMI) [Year 4]

5. Body Mass Index (BMI) [Year 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• Hope Foundation

Investigators

• Principal Investigator: Christine Ren-Fielding, M.D., NYUSOM

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 10, 2016

More Information

Additional Information:

• NYU Program for Surgical Weight Loss

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00587301
• Other Study ID Numbers: 11876; G050010
• First Posted: Jan 7, 2008
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by NYU Langone Health: Child Obesity
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Period Title: Overall Study
STARTED	119
COMPLETED	74
NOT COMPLETED	45

Baseline Characteristics

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Overall Participants	119
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.1 (1)
Sex: Female, Male (Count of Participants)
Female	79 66.4%
Male	40 33.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	11 9.2%
Not Hispanic or Latino	108 90.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.8%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	13 10.9%
White	90 75.6%
More than one race	0 0%
Unknown or Not Reported	15 12.6%
Region of Enrollment (participants) [Number]
United States	119 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Excess Weight Loss (EWL)
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	106
Mean (Standard Deviation) [percentage of EWL]	40.88 (25.12)

2. Secondary Outcome

Title	Body Mass Index (BMI)
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	106
Mean (Standard Deviation) [kg/m^2]	37.67 (8.93)

3. Primary Outcome

Title	Percentage of Excess Weight Loss (EWL)
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	95
Mean (Standard Deviation) [percentage of EWL]	44.18 (26.36)

4. Primary Outcome

Title	Percentage of Excess Weight Loss (EWL)
Time Frame	Year 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	87
Mean (Standard Deviation) [percentage of EWL]	45.19 (25.13)

5. Primary Outcome

Title	Percentage of Excess Weight Loss (EWL)
Time Frame	Year 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	81
Mean (Standard Deviation) [percentage of EWL]	42.96 (26.30)

6. Primary Outcome

Title	Percentage of Excess Weight Loss (EWL)
Time Frame	Year 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	74
Mean (Standard Deviation) [percentage of EWL]	42.6 (26.66)

7. Secondary Outcome

Title	Body Mass Index (BMI)
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	95
Mean (Standard Deviation) [kg/m^2]	36.54 (9.10)

8. Secondary Outcome

Title	Body Mass Index (BMI)
Time Frame	Year 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	87
Mean (Standard Deviation) [kg/m^2]	36 (8.94)

9. Secondary Outcome

Title	Body Mass Index (BMI)
Time Frame	Year 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	81
Mean (Standard Deviation) [kg/m^2]	36.39 (8.9)

10. Secondary Outcome

Title	Body Mass Index (BMI)
Time Frame	Year 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
Measure Participants	74
Mean (Standard Deviation) [kg/m^2]	36.75 (8.98)

Adverse Events

Time Frame	5 years
Arm/Group Title	Lap-Band
Arm/Group Description	Lap-band surgery in treatment of morbidly obese adolescents Lap-Band: Obesity and adolescents
All Cause Mortality
	Lap-Band
	Affected / at Risk (%)	# Events
Total	0/119 (0%)
Serious Adverse Events
	Lap-Band
	Affected / at Risk (%)	# Events
Total	24/119 (20.2%)
Ear and labyrinth disorders
Vertigo	1/119 (0.8%)
Gastrointestinal disorders
Abdominal pannus (excess skin)	1/119 (0.8%)
Band erosion	1/119 (0.8%)
Band slippage	12/119 (10.1%)
Cholecystitis	1/119 (0.8%)
Cholelithiasis	2/119 (1.7%)
Cholelithiasis (Aggravated)	1/119 (0.8%)
Esophageal and gastric pouch dilatation	1/119 (0.8%)
Gastric pouch dilatation	1/119 (0.8%)
Perforated appendicitis	1/119 (0.8%)
Peritonitis	1/119 (0.8%)
General disorders
Nausea	1/119 (0.8%)
Port leak	2/119 (1.7%)
Musculoskeletal and connective tissue disorders
Left tibia surgery for Blount's disease	1/119 (0.8%)
Right tibia surgery for Blount's disease	1/119 (0.8%)
Pregnancy, puerperium and perinatal conditions
Pregnancy with abortion	2/119 (1.7%)
Other (Not Including Serious) Adverse Events
	Lap-Band
	Affected / at Risk (%)	# Events
Total	99/119 (83.2%)
Blood and lymphatic system disorders
Dyslipidemia	1/119 (0.8%)
Dyslipidemia (Aggravated)	3/119 (2.5%)
Ecchymosis (post-op site)	1/119 (0.8%)
Elevated bilirubin level	1/119 (0.8%)
Elevated WBC	1/119 (0.8%)
Low Folate level	2/119 (1.7%)
Low Hb level	3/119 (2.5%)
Thrombocytopenia (small fat)	1/119 (0.8%)
Cardiac disorders
Major depression	1/119 (0.8%)
Congenital, familial and genetic disorders
Hypercholesterolemia	7/119 (5.9%)
Hypercholesterolemia (aggravated)	2/119 (1.7%)
Ear and labyrinth disorders
Ear and throat infection	1/119 (0.8%)
Endocrine disorders
Acne	2/119 (1.7%)
Gastrointestinal disorders
Abdominal pain	7/119 (5.9%)
Abdominal subcutaneous infection	1/119 (0.8%)
Abnormal EKG (junctional bradycardia)	1/119 (0.8%)
Band erosion	1/119 (0.8%)
Band intolerance	2/119 (1.7%)
Band intolerance (Chronic dysphagia)	1/119 (0.8%)
Band slippage	9/119 (7.6%)
Cholelithiasis	2/119 (1.7%)
Chronic band intolerance	3/119 (2.5%)
Chronic dysphagia with band tightening	1/119 (0.8%)
Device malfunction (Band aneurysm)	1/119 (0.8%)
Dilated esophagus and gastric pouch	1/119 (0.8%)
Erosion on antrum (endoscopy)	1/119 (0.8%)
Flatulence	1/119 (0.8%)
Gas pain	1/119 (0.8%)
Gastric pouch dilatation	16/119 (13.4%)
Gastric pouch dilation	5/119 (4.2%)
Gastric pouch formation	1/119 (0.8%)
Gastritis	2/119 (1.7%)
Gastroenteritis	2/119 (1.7%)
Heartburn	17/119 (14.3%)
Hiatal hernia	1/119 (0.8%)
Hiatal hernia (Esophagram)	1/119 (0.8%)
Kidney stones	1/119 (0.8%)
Reflux	17/119 (14.3%)
Stomach cramps	1/119 (0.8%)
Viral gastroenteritis	2/119 (1.7%)
General disorders
Acute dysphagia	2/119 (1.7%)
ADD	2/119 (1.7%)
ADHD	1/119 (0.8%)
Adrenal Hyperplasia	1/119 (0.8%)
Anemia	2/119 (1.7%)
Anorexia	1/119 (0.8%)
Back pain	1/119 (0.8%)
Behavioural issue	1/119 (0.8%)
Chest pain	1/119 (0.8%)
Common cold	6/119 (5%)
Depression	1/119 (0.8%)
Depression (Aggravated)	1/119 (0.8%)
Dysphagia	3/119 (2.5%)
Dysphagia (ER visit)	1/119 (0.8%)
Endometriosis	1/119 (0.8%)
Epigastric pain	1/119 (0.8%)
Esophageal dilatation	23/119 (19.3%)
Esophageal irritation	1/119 (0.8%)
Esophageal pain	1/119 (0.8%)
Esophagitis	6/119 (5%)
Fainting	1/119 (0.8%)
Flipped port	1/119 (0.8%)
Fungal infection	1/119 (0.8%)
Gallstones	1/119 (0.8%)
GE Reflux	2/119 (1.7%)
GERD	2/119 (1.7%)
Hair Thinning	29/119 (24.4%)
Headaches	1/119 (0.8%)
HTN (Aggravated)	1/119 (0.8%)
Hyperbilirubinemia	2/119 (1.7%)
Hyperbilirubinemia (Aggravated)	2/119 (1.7%)
Hypertriglyceridemia	1/119 (0.8%)
Hypokalemia	1/119 (0.8%)
Hypothyroidism	1/119 (0.8%)
Iron deficiency	2/119 (1.7%)
Low iron level	31/119 (26.1%)
Low iron level (Aggravated)	2/119 (1.7%)
Low Vit. B12 level	1/119 (0.8%)
Low Vit. D level	40/119 (33.6%)
Low Vit. D level (Aggravated)	12/119 (10.1%)
Low Vit. D level (Baseline:24)	1/119 (0.8%)
Migraine	3/119 (2.5%)
Narcotic addition	1/119 (0.8%)
Nausea	1/119 (0.8%)
Neck pain	1/119 (0.8%)
Port leak	1/119 (0.8%)
Port protrusion	1/119 (0.8%)
Port site pain	2/119 (1.7%)
Post op site infection	2/119 (1.7%)
Self-inflicted forearm laceration	1/119 (0.8%)
Shoulder pain	1/119 (0.8%)
Testicular torsion	1/119 (0.8%)
Vit. D Deficiency	5/119 (4.2%)
Wound dehiscence	1/119 (0.8%)
Immune system disorders
Monocleosis	2/119 (1.7%)
Mononucleosis	1/119 (0.8%)
Numbness after exposing bright light	1/119 (0.8%)
Psoriasis (Aggravated)	1/119 (0.8%)
Seasonal allergies	1/119 (0.8%)
Thrombocytopenia	2/119 (1.7%)
Tooth pain	1/119 (0.8%)
Infections and infestations
Mumps	1/119 (0.8%)
Yeast infection	1/119 (0.8%)
Musculoskeletal and connective tissue disorders
Bell's palsy	1/119 (0.8%)
Dsyphagia	1/119 (0.8%)
Knee injury (Left)	1/119 (0.8%)
Leg cramps	1/119 (0.8%)
Meniscus dislocation (Left)	1/119 (0.8%)
Meniscus tear	1/119 (0.8%)
Nervous system disorders
Anxiety	5/119 (4.2%)
Anxiety Attack	1/119 (0.8%)
Insomnia	1/119 (0.8%)
Multiple sclerosis	1/119 (0.8%)
Panic attack	1/119 (0.8%)
Panic disorder	1/119 (0.8%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	1/119 (0.8%)
Pregnancy with abortion	1/119 (0.8%)
Psychiatric disorders
Eating disorder	1/119 (0.8%)
Suicidal threats	1/119 (0.8%)
Renal and urinary disorders
Frozen pelvis	1/119 (0.8%)
Proteinuria	1/119 (0.8%)
Urinary tract infection	4/119 (3.4%)
Reproductive system and breast disorders
Adnexal mass	1/119 (0.8%)
Dysmenorrhea	2/119 (1.7%)
Respiratory, thoracic and mediastinal disorders
ARD (Acute Respiratory Failure)	1/119 (0.8%)
Bronchitis	1/119 (0.8%)
Elevated TSH	1/119 (0.8%)
Influenza	1/119 (0.8%)
Sinus infection	7/119 (5.9%)
Strep throat	1/119 (0.8%)
Upper respiratory infection	2/119 (1.7%)
Skin and subcutaneous tissue disorders
Exacerbation of Eczema	1/119 (0.8%)
Excess skin	2/119 (1.7%)
Excess skin irritation	1/119 (0.8%)
Facial skin infection	1/119 (0.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.