Clinical trial NCT04766801: Adolescents Bariatric Surgery Cohort Survey
Official title: Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Obesity, Morbid
Obesity, Adolescent
Keywords: gastric banding
complications
weight loss
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients treated in our hospital for morbid obesity (BMI \>= 35 Kg.M-2) through different programs with lifestyle and nutritional interventions and, for those who requested it, the possibility of bariatric surgery.

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.

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.

Primary outcomes:
measure: Change of weight parameters at 2 years compared to preoperative baseline
timeFrame: 2 years
Secondary outcomes:
measure: Changes of insulin resistance at 2 years
timeFrame: 2 years
measure: Evaluation of dyslipidemia
timeFrame: 2 years
measure: Evaluation of liver steatosis
timeFrame: 2 years
measure: Resolution of comorbidities associated with obesity
timeFrame: 2 years
measure: Monitoring of psychiatric profile
timeFrame: 2 years
measure: Evaluation of quality of life
timeFrame: 2 years
measure: Evaluation of cosmetic satisfaction
timeFrame: 12 months postoperative
measure: Surgical complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
state: Maine Et Loire
Study officials:
affiliation: University Hospital of Angers
name: Françoise Schmitt, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: