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

Hiatus Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397616
• Other study ID #: KEK-ZH-Nr. 2014-0013
• Status: Completed
• Start date: January 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: July 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia, Hiatal
• Hiatus Hernia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Division of Gastroenterology, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms		1 months
Secondary	Differences in hernia size between sitting and recumbent position as well as between liquid swallows, free drinking and test meal.		1 hour
Secondary	Diagnostic accuracy for hernia diagnosis by HRM for sitting, and recumbent position, free drinking and test meal.		1 hour
Secondary	Correlation of pH-impedance measurements (if available) with manometric and clinical data.		1 hour
Secondary	Correlation of various measurements describing esophageal motility according to Chicago classification with type of hernia, clinical symptoms and pH-impedance measurements		1 hour
Secondary	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
Secondary	Correlation of body measurements (body mass index, BMI, waist circumference) of patients with type of hernia, clinical symptoms and pH-impedance measurements		1 hour
Secondary	Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms		1 hour
Secondary	Prediction of reflux symptoms using a model including hernia and esophageal peristalsis characteristics, visceral sensitivity (balloon inflation) and anthropometric measurements		1 hour