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Adolescents Bariatric Surgery Cohort Survey

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04766801
Acronym
BariAdo
Enrollment
100
Registered
2021-02-23
Start date
2008-01-01
Completion date
2030-12-31
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Obesity, Morbid, Obesity, Adolescent

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

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Change of weight parameters at 2 years compared to preoperative baseline2 yearsEvaluation of weight loss by weight (Kg), body mass index (BMI, Kg.m-2) and excess body weight (EBWL, %) changes

Secondary

MeasureTime frameDescription
Evaluation of dyslipidemia2 yearsEvaluation of lipid profile (cholesterol, triglycerides)
Evaluation of liver steatosis2 yearsEvaluation of liver steatosis and NAFLD on US exam and liver elastometry
Resolution of comorbidities associated with obesity2 yearsClinical 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 years2 yearsEvaluation of insulin resistance by measure of the HOMA index
Evaluation of quality of life2 yearsEvaluation of obesity-related QOL by the use of the PedsQL scale
Evaluation of cosmetic satisfaction12 months postoperativeEvaluation of the patient's level of satisfaction with regards to their surgical scar using the POSAS scale
Surgical complications2 yearsMonitoring of the occurrence of surgical complications and their severity thanks to the Clavien-Dindo scale at each medical consultation
Monitoring of psychiatric profile2 yearsClinical evaluation of the presence/absence of psychiatric disorders such as binge eating, depression, etc...

Countries

France

Contacts

Primary ContactFrançoise Schmitt, MD-PhD
FrSchmitt@chu-angers.fr0241354290
Backup ContactRégis Coutant, MD-PhD
ReCoutant@chu-anger.fr0241355655

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026