Adolescents Bariatric Surgery Cohort Survey

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.

Conditions
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Bariatric Surgery Candidate, Obesity, Morbid, Obesity, Adolescent

Intervention / Treatment
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* Procedure: Laparoscopic adjustable gastric banding


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic adjustable gastric banding|Weight-loss surgery, with the use of gastric banding|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of insulin resistance at 2 years | Evaluation of insulin resistance by measure of the HOMA index | 2 years | 
| Evaluation of dyslipidemia | Evaluation of lipid profile (cholesterol, triglycerides) | 2 years | 
| Evaluation of liver steatosis | Evaluation of liver steatosis and NAFLD on US exam and liver elastometry | 2 years | 
| Resolution of comorbidities associated with obesity | Clinical evaluation of the presence/absence of hypertension, sleep apnea, orthopedic disorders and polycystic ovary at two years, compared to Baseline characteristics | 2 years | 
| Monitoring of psychiatric profile | Clinical evaluation of the presence/absence of psychiatric disorders such as binge eating, depression, etc... | 2 years | 
| Evaluation of quality of life | Evaluation of obesity-related QOL by the use of the PedsQL scale | 2 years | 
| Evaluation of cosmetic satisfaction | Evaluation of the patient's level of satisfaction with regards to their surgical scar using the POSAS scale | 12 months postoperative | 
| Surgical complications | Monitoring of the occurrence of surgical complications and their severity thanks to the Clavien-Dindo scale at each medical consultation | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric banding, complications, weight loss