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临床试验/NCT07197619
NCT07197619招募中不适用

Effect of Hernia Sac Excision on Crural Tension in Paraesophageal Hernia Repair

Spectrum Health Hospitals1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年8月27日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

Paraesophageal hernia can cause significant clinical symptoms, including reflux, chest pain, nausea, regurgitation, and even life threatening conditions such as bowel obstruction, and gastric volvulus. Repair of a paraesophageal hernia is associated with significant recurrence rate, with primary repair often in excess of 50%. Hernia recurrence and revisional surgery significantly increase the likelihood of complications and decreased quality of life.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients age 18-80 undergoing elective or emergent paraesophageal hernia repair for symptomatic paraesophageal hernia will be eligible for enrollment into the study.

排除标准

  • Patients with previous history of esophageal, gastric, diaphragmatic, or anti-reflux surgery will be excluded.

结局指标

主要结局

Primary Outcome

时间窗: Immediately following procedure

Intraoperative Pre and Post hernia sac excision crural tension measurement will be collected.

次要结局

  • Competeness of hernia sac excision(Immediately following procedure)
  • Paraesophageal hernia type(Immediately following procedure)
  • Mesh useage(Immediately following procedure)
  • Complications(30-days post-op)
  • Comparing dephographics(30-days post-op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Banks-Venegoni

Principle Investigator

Spectrum Health Hospitals

研究点 (1)

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