N/A
Completed N=57
Laparoscopic Adjustable Gastric Banding in Adolescents
Source: ClinicalTrials.gov NCT01619488 ↗Enrolled (actual)
57
Serious AEs
3.5%
Results posted
Jun 2023
Primary outcomePrimary: Total Weight Loss — 11.35 kilograms
Summary
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Weight Loss |
11.35 | — |
| SECONDARY Insulin Resistance |
12.5 | — |
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. Informational only — not medical advice.