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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02397616
Enrollment
380
Registered
2015-03-25
Start date
2015-01-31
Completion date
2017-12-01
Last updated
2018-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiatus Hernia

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.

Interventions

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

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms1 months

Secondary

MeasureTime frame
Diagnostic accuracy for hernia diagnosis by HRM for sitting, and recumbent position, free drinking and test meal.1 hour
Correlation of pH-impedance measurements (if available) with manometric and clinical data.1 hour
Correlation of various measurements describing esophageal motility according to Chicago classification with type of hernia, clinical symptoms and pH-impedance measurements1 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 body measurements (body mass index, BMI, waist circumference) of patients with type of hernia, clinical symptoms and pH-impedance measurements1 hour
Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms1 hour
Prediction of reflux symptoms using a model including hernia and esophageal peristalsis characteristics, visceral sensitivity (balloon inflation) and anthropometric measurements1 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 HRM1 hour

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026