Идёт набор NCT04766801

Adolescents Bariatric Surgery Cohort Survey

— Наблюдательное Bariatric Surgery Candidate Obesity, Morbid Obesity, Adolescent

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Laparoscopic adjustable gastric banding.
Кому может быть актуально: Состояния в реестре: Bariatric Surgery Candidate, Obesity, Morbid, Obesity, Adolescent. Базовые параметры: 14 лет — 20 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура Laparoscopic adjustable gastric banding
Weight-loss surgery, with the use of gastric banding

Первичные конечные точки

Change of weight parameters at 2 years compared to preoperative baseline [Срок оценки: 2 years]

Вторичные конечные точки (8)

Changes of insulin resistance at 2 years [Срок оценки: 2 years]
Evaluation of dyslipidemia [Срок оценки: 2 years]
Evaluation of liver steatosis [Срок оценки: 2 years]
Resolution of comorbidities associated with obesity [Срок оценки: 2 years]
Monitoring of psychiatric profile [Срок оценки: 2 years]
Evaluation of quality of life [Срок оценки: 2 years]
Evaluation of cosmetic satisfaction [Срок оценки: 12 months postoperative]
Surgical complications [Срок оценки: 2 years]

Критерии участия

Критерии включения

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...)