N/A
N=119
Lap-Band Surgery on Adolescents for Safety and Efficacy
Obesity · DM
Bottom Line
View on ClinicalTrials.gov: NCT00587301 ↗Enrolled (actual)
119
Serious AEs
20.2%
Results posted
Mar 2022
Primary outcome: Primary: Percentage of Excess Weight Loss (EWL) — 40.88 percentage of EWL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lap-Band (Device)
- Age
- Pediatric · 14+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Excess Weight Loss (EWL) |
42.6 | — |
| PRIMARY Percentage of Excess Weight Loss (EWL) |
42.6 | — |
| PRIMARY Percentage of Excess Weight Loss (EWL) |
42.6 | — |
| PRIMARY Percentage of Excess Weight Loss (EWL) |
42.6 | — |
| PRIMARY Percentage of Excess Weight Loss (EWL) |
42.6 | — |
| SECONDARY Body Mass Index (BMI) |
36.75 | — |
| SECONDARY Body Mass Index (BMI) |
36.75 | — |
| SECONDARY Body Mass Index (BMI) |
36.75 | — |
| SECONDARY Body Mass Index (BMI) |
36.75 | — |
| SECONDARY Body Mass Index (BMI) |
36.75 | — |
Summary
This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.
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
Data sourced from ClinicalTrials.gov (NCT00587301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.