跳至主要内容
临床试验/NCT05357443
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

Sanford Health2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月31日最近更新:
适应症

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
2
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

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.

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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