Bariatric Surgery Candidate, Obesity, Morbid, Obesity, Adolescent
Conditions
Keywords
gastric banding, complications, weight loss
Brief 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.
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
Weight-loss surgery, with the use of gastric banding
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of dyslipidemia | 2 years | Evaluation of lipid profile (cholesterol, triglycerides) |
| Evaluation of liver steatosis | 2 years | Evaluation of liver steatosis and NAFLD on US exam and liver elastometry |
| Resolution of comorbidities associated with obesity | 2 years | Clinical evaluation of the presence/absence of hypertension, sleep apnea, orthopedic disorders and polycystic ovary at two years, compared to Baseline characteristics |
| Changes of insulin resistance at 2 years | 2 years | Evaluation of insulin resistance by measure of the HOMA index |
| Evaluation of quality of life | 2 years | Evaluation of obesity-related QOL by the use of the PedsQL scale |
| Evaluation of cosmetic satisfaction | 12 months postoperative | Evaluation of the patient's level of satisfaction with regards to their surgical scar using the POSAS scale |
| Surgical complications | 2 years | Monitoring of the occurrence of surgical complications and their severity thanks to the Clavien-Dindo scale at each medical consultation |
| Monitoring of psychiatric profile | 2 years | Clinical evaluation of the presence/absence of psychiatric disorders such as binge eating, depression, etc... |
Countries
France