NCT02397616已完成不适用
Effects of Position and a Test Meal on Esophago-gastric Junction Morphology and Function Assessed by High-resolution Impedance Manometry (HRM)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms
研究概览
简要总结
Retrospective analysis for HRM measurements using liquid swallows and a test meal for the presence of hiatal hernia. The investigators will correlate hernia descriptions with presence of acidic reflux and clinical complaints.
详细描述
We will retrospectively analyze all patients referred to hour unit for high-resolution esophageal manometry. These patients have been tested using liquid swallows and a test meal. We will analyze the HRM measurements for presence of manometric signs of hiatal hernia and determine predictive factors for hernia presence. We will correlate hernia description versus presence of acid reflux, clinical complaints and HRM measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All patients referred to our functional lab for esophageal high-resolution manometry from January 2013 - December 20165
- •Lack of documentation of patient preferences against usage of medical data for biomedical research
- •Male and female patients ≥18 years of age
排除标准
- •Age under 18 years
- •Patient's wishes against scientific use of their clinical data
结局指标
主要结局
Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms
时间窗: 1 months
次要结局
- Differences in hernia size between sitting and recumbent position as well as between liquid swallows, free drinking and test meal.(1 hour)
- Correlation of pH-impedance measurements (if available) with manometric and clinical data.(1 hour)
- Correlation of hernia diagnosis and hernia size according to imaging exams (if available: CT scan, fluoroscopy) and endoscopy (if available) with hernia diagnosis by HRM(1 hour)
- Prediction of reflux symptoms using a model including hernia and esophageal peristalsis characteristics, visceral sensitivity (balloon inflation) and anthropometric measurements(1 hour)
- Diagnostic accuracy for hernia diagnosis by HRM for sitting, and recumbent position, free drinking and test meal.(1 hour)
- Correlation of various measurements describing esophageal motility according to Chicago classification with type of hernia, clinical symptoms and pH-impedance measurements(1 hour)
- Correlation of body measurements (body mass index, BMI, waist circumference) of patients with type of hernia, clinical symptoms and pH-impedance measurements(1 hour)
- Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms(1 hour)
研究者
研究点 (1)
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