跳至主要内容
临床试验/NCT04901429
NCT04901429招募中不适用

Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

Baylor Research Institute2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Esophageal pH monitoring

研究概览

简要总结

The purpose of this study is to investigate the efficacy of performing a truncal vagotomy along with a sleeve to bypass revision surgery in reducing the severity and/or incidence of gastroesophageal reflux disease (GERD) post-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
Single (Participant)

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

  • Participating subjects will need to be >18yrs of age and eligible for sleeve to bypass revision bariatric surgery.
  • Undergoing sleeve to bypass revision bariatric surgery.

排除标准

  • Patients who are under the age of
  • Not eligible for sleeve to bypass revision bariatric surgery.

结局指标

主要结局

Esophageal pH monitoring

时间窗: approximately 6 months post operation

Esophageal pH monitoring

GERD-HRQL scores

时间窗: approximately 6 months post operation

GERD-HRQL scores

Reflux symptom index questionnaire

时间窗: approximately 6 months post operation

Reflux symptom index questionnaire

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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