Adolescents Bariatric Surgery Cohort Survey
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic adjustable gastric banding.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery Candidate, Obesity, Morbid, Obesity, Adolescent. Basic parameters: 14 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.
Overview
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.
Detailed description
Since 2008, in France, certain university hospitals have been eligible to perform bariatric surgery for adolescents. It was therfore possible to define its feasibility, potential complications and specific indications.
This led to recommandations published by Health Authorities (HAS) in 2016. However, it seems imperative to continue monitoring these patients in order to improve their management, especially as the use of these surgical techniques becomes increasingly widespread.
The Angers University Hospital is one of the leading hospitals when it comes bariatric surgery for adolescents through its use of gastric bands.
The aim of this protocol is to update data on how effective this surgery is on weight loss and obesity-associated comorbidities, and to monitor medical, psychological and surgical complications associated with this treatment.
Interventions
- Procedure Laparoscopic adjustable gastric banding
Weight-loss surgery, with the use of gastric banding
Primary outcome measures
- Change of weight parameters at 2 years compared to preoperative baseline [Time frame: 2 years]
Secondary outcome measures (8)
- Changes of insulin resistance at 2 years [Time frame: 2 years]
- Evaluation of dyslipidemia [Time frame: 2 years]
- Evaluation of liver steatosis [Time frame: 2 years]
- Resolution of comorbidities associated with obesity [Time frame: 2 years]
- Monitoring of psychiatric profile [Time frame: 2 years]
- Evaluation of quality of life [Time frame: 2 years]
- Evaluation of cosmetic satisfaction [Time frame: 12 months postoperative]
- Surgical complications [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- University Hospital of Angers — Angers
Identifiers
NCT: NCT04766801 · 2007-06