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

Completed

• Conditions: Hiatus Hernia

• Registration Number: NCT02397616
• Lead Sponsor: University of Zurich

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 Description

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• 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

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Exclusion Criteria

• Age under 18 years
• Patient's wishes against scientific use of their clinical data

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms	1 months

Secondary Outcome Measures

Name	Time	Method
Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms	1 hour
Correlation of pH-impedance measurements (if available) with manometric and clinical data.	1 hour
Differences in hernia size between sitting and recumbent position as well as between liquid swallows, free drinking and test meal.	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

Trial Locations

Locations (1)

Division of Gastroenterology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland