跳至主要内容
临床试验/NCT03374930
NCT03374930已完成不适用

Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
1
主要终点
presence of dysphagia

研究概览

简要总结

The main objective of this study is to evaluate, in a prospective cohort, the link between preoperative contractile reserve of oesophagus evaluated by high resolution manometry (HRM) and the occurrence of post operative dysphagia after anti-reflux surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • •Patient with an indication validated at a fundoplication directed by a visceral surgeon from Vienne county
  • •Patient sent for the realization of a preoperative HRM,
  • •Patient giving consent to participate in the study.

排除标准

  • •Patient unable to sign a consent or protected (minors, pregnant women, patient under guardianship),
  • •History of oesophageal surgery or radiotherapy,
  • •History of systemic pathology with oesophageal involvement,
  • •Contraindication to an oesophageal manometry : altered general status and vigilance , important swallowing disorders

研究组 & 干预措施

Multiple rapid swallows test

Other

Multiple rapid swallows test consists in giving to patient 4 to 6 sips of 2 mL of water, with an interval less than 4 seconds between the different sips.

干预措施: Multiple rapid swallows test (Procedure)

结局指标

主要结局

presence of dysphagia

时间窗: 3 months

clinically evaluated by the surgeon

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 (1)

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