Adolescents Bariatric Surgery Cohort Survey

NCT04766801 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Angers

Phase

Observational

Started

2008-01-01

Last updated

2021-02-23

Condition(s) studied

Bariatric Surgery CandidateObesity, MorbidObesity, Adolescent

Investigational drug(s) / intervention(s)

Laparoscopic adjustable gastric banding

Laparoscopic adjustable gastric banding: Weight-loss surgery, with the use of gastric banding

Study summary

Obesity affects 3%-4% of the pediatric population and leads to cardiac mortality during adult life. Bariatric surgery is the best treatment for weight loss and preventing obesity associated comorbidities in adults, but its applications and safety are yet to be defined for adolescents.

Eligibility

Sex

ALL

Min age

14 Years

Max age

20 Years

Healthy volunteers

Inclusion Criteria: * Patients aged 14-20 years of age and asking for bariatric surgery * BMI \>= 40 Kg.m-2 or \>= 35 Kg.m-2 with major obesity-related comorbidities (hypertension, diabetes, sleep apnea, etc...) Exclusion Criteria: * An unstable psychiatric disorder * Bariatric surgery anesthesic contraindications * Having not completed a minimum of six months of the pre operative program * Lack of consent from the patient or the patient's relatives.

Primary outcome measure(s)

Change of weight parameters at 2 years compared to preoperative baseline — 2 years
Evaluation of weight loss by weight (Kg), body mass index (BMI, Kg.m-2) and excess body weight (EBWL, %) changes

Trial sites (1)

Facility	City	Region	Status
University Hospital of Angers	Angers	Maine Et Loire	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04766801 on ClinicalTrials.gov ↗ ← All trials in France