Prospective National Cohort Study on Swedish Adjustable Gastric Band (SAGB) for Gastroplasty (Étude de Cohorte Nationale Prospective de l'Implant Annulaire Ajustable Pour Gastroplastie SAGB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 1
- 主要终点
- Mean Excess Weight Change
研究概览
简要总结
Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.
Verification by means of a screening log (exhaustive list of all bariatric procedures performed by participating surgeons between the beginning and end of the cohort inclusion period) requested from all centers.
No comparator group. No randomization or blinding techniques
详细描述
Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.
The study is originated in collaboration with HAS in France and has a target of 500 patients treated with gastric banding because of morbid obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •morbidly obese patients (BMI>35 with comorbidities or BMI>40 without comorbidities) in France selected for gastric banding based on standard local clinical practice
排除标准
- •lower BMI, contraindications based on local clinical assessment
结局指标
主要结局
Mean Excess Weight Change
时间窗: 3 years follow up
Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).
Mean BMI Change
时间窗: 3 years follow-up
Mean change in BMI for valid subjects
次要结局
未报告次要终点