Adolescents Bariatric Surgery Cohort Survey

Bariatric Surgery Candidate Clinical Trial

— BariAdo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766801
• Other study ID #: 2007-06
• Status: Recruiting
• Start date: January 1, 2008
• Est. completion date: December 31, 2030

Study information

• Verified date: February 2021
• Source: University Hospital, Angers
• Contact: Françoise Schmitt, MD-PhD
• Phone: 0241354290
• Email: FrSchmitt[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2030
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 20 Years

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Obesity, Adolescent
• Obesity, Morbid
• Pediatric Obesity

Intervention

Procedure:
• Laparoscopic adjustable gastric banding
Weight-loss surgery, with the use of gastric banding

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers	Maine Et Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of insulin resistance at 2 years	Evaluation of insulin resistance by measure of the HOMA index	2 years
Secondary	Evaluation of dyslipidemia	Evaluation of lipid profile (cholesterol, triglycerides)	2 years
Secondary	Evaluation of liver steatosis	Evaluation of liver steatosis and NAFLD on US exam and liver elastometry	2 years
Secondary	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
Secondary	Monitoring of psychiatric profile	Clinical evaluation of the presence/absence of psychiatric disorders such as binge eating, depression, etc...	2 years
Secondary	Evaluation of quality of life	Evaluation of obesity-related QOL by the use of the PedsQL scale	2 years
Secondary	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
Secondary	Surgical complications	Monitoring of the occurrence of surgical complications and their severity thanks to the Clavien-Dindo scale at each medical consultation	2 years