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临床试验/NCT02060500
NCT02060500已完成不适用

Cardiaplication: A Prospective Observational Trial

Emory University0 个研究点目标入组 8 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
主要终点
Determine pH impedance probe results of Cardiaplication

研究概览

简要总结

Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of medical therapy, many children are referred for surgical intervention. Techniques have evolved over the last 50 years; however, benefits in children remain the center of debate in many surgical forums. This is primarily owing to the high incidence of recurrence of reflux and need for revisions later in life. Some clinicians theorize that the pathophysiology of reflux in infants is different from that of the population at large, and that the traditional operation may not be the best suited for this patient population. We propose a study to test an alternative plication technique for modifying the gastro-esophageal junction at the Angle of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve which will limit reflux without disrupting the diaphragmatic crura, thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are too tight.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD.

排除标准

  • Inability to obtain consent
  • Surgeon preference

结局指标

主要结局

Determine pH impedance probe results of Cardiaplication

时间窗: At 3 months post-operatively

We will perform a pH impedance probe on all patients at 3 months post-op (+/- 30 days). We are looking for a statistically significant improvement in per-cent time the pH is \<= 4.

次要结局

  • Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants(1 year post-op)

研究者

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

Mark L. Wulkan, M.D.

Principal Investigator

Emory University

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