Adolescents Bariatric Surgery Cohort Survey (BariAdo)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Bariatric Surgery Candidate; Obesity, Adolescent
• Intervention / Treatment: Procedure: Laparoscopic adjustable gastric banding

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Françoise Schmitt, MD-PhD; Phone Number: +33 0241354290; Email: FrSchmitt@chu-angers.fr
• Study Contact Backup: Name: Régis Coutant, MD-PhD; Phone Number: +33 0241355655; Email: ReCoutant@chu-anger.fr

Study Locations

• France
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49933
      • Recruiting
      • University hospital of Angers
      • Contact: Françoise Schmitt, MD-PhD; Phone Number: +33 0241354290; Email: FrSchmitt@chu-angers.fr
      • Contact: Régis Coutant, MD-PhD; Phone Number: +33 0241355655; Email: ReCoutant@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Françoise Schmitt, MD-PhD, University hospital of Angers

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: complications; weight loss; gastric banding
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Obesity, Morbid
• Other Study ID Numbers: 2007-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No