NCT05357443进行中（未招募）不适用
Effect of Vagus Nerve Preservation During Gastric Bypass on Gastrin Level and Marginal Ulcer Formation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Marginal Ulcer
研究概览
简要总结
Evaluation of serum gastrin levels and their effect on marginal ulcer formation.
详细描述
Prospective, randomized, interventional trial. Participants will be randomized to one of two surgical techniques, either with transection of the vagal nerves, or without. Outcomes including compare marginal ulcer rates will be compared using serum gastrin levels before and after surgery and gastric pH during surgery.
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
- 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
- 是
入选标准
- •Age 18 years and older
- •Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
- •Capable of giving signed informed consent.
排除标准
- •Under 18 years of age
- •Ineligible for gastric bypass surgery
- •Pregnant women or women actively seeking to become pregnant.
研究组 & 干预措施
Gastric Bypass with Transection of Vagal Nerves
Active Comparator
干预措施: Gastric bypass with transection of vagal nerves (Procedure)
Gastric Bypass Without Transection of Vagal Nerves
Placebo Comparator
干预措施: Gastric bypass without transection of vagal nerves (Procedure)
结局指标
主要结局
Incidence of Marginal Ulcer
时间窗: From surgical intervention to five years after surgery
Number of participants with a change in serum gastrin levels compared pre- and post-surgery.
次要结局
未报告次要终点
研究者
研究点 (1)
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