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Completed

NCT Number: NCT02397616

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

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.

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Key information

Conditions

Hiatus Hernia Hernia Hernia, Diaphragmatic Hernia, Hiatal Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

high resolution esophageal manometry

Other

high resolution esophageal manometry using liquid and solid swallows and a test meal.

Primary outcomes

  1. Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms

    Time frame: 1 months

Secondary outcomes

  1. Differences in hernia size between sitting and recumbent position as well as between liquid swallows, free drinking and test meal.

    Time frame: 1 hour

  2. Diagnostic accuracy for hernia diagnosis by HRM for sitting, and recumbent position, free drinking and test meal.

    Time frame: 1 hour

  3. Correlation of pH-impedance measurements (if available) with manometric and clinical data.

    Time frame: 1 hour

  4. 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

  5. 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

  6. 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

  7. Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms

    Time frame: 1 hour

  8. Prediction of reflux symptoms using a model including hernia and esophageal peristalsis characteristics, visceral sensitivity (balloon inflation) and anthropometric measurements

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2015
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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