N/A
N=57
Laparoscopic Adjustable Gastric Banding in Adolescents
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01619488 ↗Enrolled (actual)
57
Serious AEs
3.5%
Results posted
Jun 2023
Primary outcome: Primary: Total Weight Loss — 11.35 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adjustable Gastric Band (Device)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Kirk Reichard
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Weight Loss |
11.35 | — |
| SECONDARY Insulin Resistance |
12.5 | — |
Summary
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01619488). 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.