NCT05080634招募中不适用
Analysis of Incidence and Risk Factors Associated With Gastroesophageal Reflux Disease and Esophagitis After Peroral Endoscopic Myotomy
Maria Sklodowska-Curie National Research Institute of Oncology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6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
- 100
- 试验地点
- 1
- 主要终点
- The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM)
研究概览
简要总结
Achalasia is an uncommon disorder that results from the degeneration of ganglion cells of the myenteric plexus in the lower esophageal wall. Peroral endoscopic myotomy (POEM) is a minimally invasive procedure capable of overcoming limitations of achalasia treatments. This study aimed to: 1) identify the prevalence of reflux esophagitis and asymptomatic GERD in patients who underwent POEM, and 2) evaluate patient and intraprocedural variables associated with post-POEM GERD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males and females who are 18 years of age and older and are willing to sign an Informed Consent Form (ICF)
- •Achalasia patients who underwent POEM
排除标准
- •Lack of written consent for participation in the study
- •Conditions which are contraindication to Esophagogastroscopy and High-resolution Esophageal Manometry
结局指标
主要结局
The prevalence of gastroesophageal reflux after peroral endoscopic myotomy (POEM)
时间窗: 36 Months
次要结局
未报告次要终点
研究者
研究点 (1)
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