Evaluation of the Efficiency and Complications Associated With the Surgical Treatment of Obesity by Laparoscopic Adjustable Gastric Banding in an Adolescent Population.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of weight parameters at 2 years compared to preoperative baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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...)
排除标准
- •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.
结局指标
主要结局
Change of weight parameters at 2 years compared to preoperative baseline
时间窗: 2 years
Evaluation of weight loss by weight (Kg), body mass index (BMI, Kg.m-2) and excess body weight (EBWL, %) changes
次要结局
- Evaluation of liver steatosis(2 years)
- Evaluation of dyslipidemia(2 years)
- Changes of insulin resistance at 2 years(2 years)
- Monitoring of psychiatric profile(2 years)
- Resolution of comorbidities associated with obesity(2 years)
- Evaluation of quality of life(2 years)
- Surgical complications(2 years)
- Evaluation of cosmetic satisfaction(12 months postoperative)