4XL-Study - Obesity Surgery in Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- BMI and weight loss
研究概览
简要总结
The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.
详细描述
The study has two intervention arms:
Experimental: Group A Surgery; laparoscopic gastric bypass
Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center.
All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 13 and 18 years of age at inclusion
- •Tanner stage 4-5
- •BMI > 40 kg/m2 or BMI > 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor)
- •At least one year multidisciplinary treatment completed
排除标准
- •Tanner stage < 4
- •Substantial risk for lack of compliance
- •Obesity syndrome (e.g., Prader Willi syndrome)
- •Obesity related to brain damage
- •Serious general disease
- •Monogenic obesity
研究组 & 干预措施
Group A
Laparoscopic Gastric Bypass
干预措施: Laparoscopic gastric bypass (Procedure)
Group B
Standard conservative treatment. Patients from Child Obesity Registry of Vestfold.
干预措施: Standard conservative treatment (Behavioral)
结局指标
主要结局
BMI and weight loss
时间窗: Baseline, Year 1, 2, 5, 10
Surgical or standard conservative treatment
次要结局
- Eating Disorders (Child Eating Behavior Questionnaire)(10 years)
- Quality of Life (KINDL)(10 years)
- Self-Esteem (Rosenberg Self-Esteem scale)(10 years)
- Blood sample results(10 years)
- Mental Health (Development and Well-Being Assessment, DAWBA)(10 years)
- Surgical and Medical Complications(10 years)
研究者
Jøran Hjelmesæth
PhD, MD
Sykehuset i Vestfold HF