NCT01078181Unknown不适用
A Prospective Randomized Comparison on Weight Loss After Gastric Bypass and Banded Gastric Bypass Using the A.M.I B-Band (Soft Gastric Bypass Band)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Excessive Weight Loss
研究概览
简要总结
This is a prospective randomized Study comparing Weight loss, Esophageal Motility and Reflux in lap. Gastric Bypass vs. lap. Banded-Gastric Bypass using the A.M.I. Soft Gastric Bypass Band (B-Band.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 40 or BMI > 35 + hypertension/diabetes mellitus
- •pH metry and manometry preoperatively
排除标准
- •formerly operations of the stomach
- •formerly open abdominal surgery
- •malignancy within the last 5 years
- •formerly gastric banding
研究组 & 干预措施
banded gastric bypass
Active Comparator
Banded gastric bypass (circular anastomosis 21mm) using the A.M.I. B-Band (Soft Gastric Bypass Band)
干预措施: gastric bypass (Procedure)
non-banded gastric bypass
Active Comparator
non-banded gastric bypass (circular anastomosis 21mm)
干预措施: gastric bypass (Procedure)
结局指标
主要结局
Excessive Weight Loss
时间窗: 3 years
次要结局
- pouch dilatation, band migration, reflux, esophageal motility(3 years)
研究者
研究点 (1)
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