Cardiaplication: A Prospective Observational Trial
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
- 否
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
Mark L. Wulkan, M.D.
Principal Investigator
Emory University
