Effect on Early Weight Loss by Adjusting Gastric Band During Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
研究概览
简要总结
Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients undergoing gastric band surgery
- •Over 18 years of age
排除标准
- •Actively bleeding varices
结局指标
主要结局
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
时间窗: 4-6 weeks post surgery
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
时间窗: 4-6 weeks post surgery
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
时间窗: 12m post surgery
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)
时间窗: 12m post surgery
次要结局
- Number of Band Adjustments Required in the First Year After Surgery(12 months)