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NCT Number: NCT04766801

Adolescents Bariatric Surgery Cohort Survey

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.

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Adolescent Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Weight Loss

Age range

14 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic Adjustable Gastric Banding

Procedure

Weight-loss surgery, with the use of gastric banding

Primary outcomes

  1. Change of weight parameters at 2 years compared to preoperative baseline

    Time frame: 2 years

    Evaluation of weight loss by weight (Kg), body mass index (BMI, Kg.m-2) and excess body weight (EBWL, %) changes

Secondary outcomes

  1. Changes of insulin resistance at 2 years

    Time frame: 2 years

    Evaluation of insulin resistance by measure of the HOMA index

  2. Evaluation of dyslipidemia

    Time frame: 2 years

    Evaluation of lipid profile (cholesterol, triglycerides)

  3. Evaluation of liver steatosis

    Time frame: 2 years

    Evaluation of liver steatosis and NAFLD on US exam and liver elastometry

  4. Resolution of comorbidities associated with obesity

    Time frame: 2 years

    Clinical evaluation of the presence/absence of hypertension, sleep apnea, orthopedic disorders and polycystic ovary at two years, compared to Baseline characteristics

  5. Monitoring of psychiatric profile

    Time frame: 2 years

    Clinical evaluation of the presence/absence of psychiatric disorders such as binge eating, depression, etc...

  6. Evaluation of quality of life

    Time frame: 2 years

    Evaluation of obesity-related QOL by the use of the PedsQL scale

  7. Evaluation of cosmetic satisfaction

    Time frame: 12 months postoperative

    Evaluation of the patient's level of satisfaction with regards to their surgical scar using the POSAS scale

  8. Surgical complications

    Time frame: 2 years

    Monitoring of the occurrence of surgical complications and their severity thanks to the Clavien-Dindo scale at each medical consultation

Study contacts

Contact information is provided by the study sponsor or research team.

Françoise Schmitt, MD-PhD

CONTACT

[email protected]

0241354290 ext. +33

Régis Coutant, MD-PhD

CONTACT

[email protected]

0241355655 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: BariAdo

Important dates

Study start
2008
Primary completion
2021
Study completion
2030
First posted
Feb 23, 2021
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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