Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- BMI development
研究概览
简要总结
The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.
Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.
详细描述
Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI >40kg/m2 in the adolescence will remain morbidly obese also in their adult life.
The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.
Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >40 kg/m2 or BMI>35 with comorbidity
- •Pass psychological evaluation
- •Puberty status Tanner 4-5
- •At least one year with active conservative treatment that failed
排除标准
- •Lack of compliance
- •Specific obesity syndrome as Praeder Willis
- •Obesity due to brain injury
- •Severe general disease
- •Specific genetic defect (MC4R, Leptin deficiency)
结局指标
主要结局
BMI development
时间窗: 10 years
次要结局
- Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern.(10 years)