Clinical Trial: Effects of Position and a Test Meal on Esophago-gastric Junction Morphology and Function Assessed by High-resolution Impedance Manometry (HRM)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Effects of Position and a Test Meal on Esophago-gastric Junction Morphology and Function Assessed by High-resolution Impedance Manometry (HRM)

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Zurich

Current Primary Outcome: Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms [ Time Frame: 1 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Differences in hernia size between sitting and recumbent position as well as between liquid swallows, free drinking and test meal. [ Time Frame: 1 hour ]
  • Diagnostic accuracy for hernia diagnosis by HRM for sitting, and recumbent position, free drinking and test meal. [ Time Frame: 1 hour ]
  • Correlation of pH-impedance measurements (if available) with manometric and clinical data. [ Time Frame: 1 hour ]
  • Correlation of various measurements describing esophageal motility according to Chicago classification with type of hernia, clinical symptoms and pH-impedance measurements [ Time Frame: 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 [ Time Frame: 1 hour ]
  • Correlation of body measurements (body mass index, BMI, waist circumference) of patients with type of hernia, clinical symptoms and pH-impedance measurements [ Time Frame: 1 hour ]
  • Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms [ Time Frame: 1 hour ]
  • Prediction of reflux symptoms using a model including hernia and esophageal peristalsis characteristics, visceral sensitivity (balloon inflation) and anthropometric measurements [ Time Frame: 1 hour ]


Original Secondary Outcome: Same as current

Information By: University of Zurich

Dates:
Date Received: March 18, 2015
Date Started: January 2015
Date Completion: December 2016
Last Updated: December 10, 2015
Last Verified: December 2015