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.

Study Overview

• Status: Completed
• Conditions: Hiatus Hernia
• Intervention / Treatment: Other: high resolution esophageal manometry

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 Type: Observational
• Enrollment (Actual): 380

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Division of Gastroenterology, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to hour unit for high resolution manometry (patients with dysphagia, reflux or other complaints)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences in hernia size between sitting and recumbent position as well as between liquid swallows, free drinking and test meal.	1 hour
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 measurements	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
Correlation of body measurements (body mass index, BMI, waist circumference) of patients with type of hernia, clinical symptoms and pH-impedance measurements	1 hour
Correlation of visceral sensitivity (determined by balloon inflation) with reflux symptoms	1 hour
Prediction of reflux symptoms using a model including hernia and esophageal peristalsis characteristics, visceral sensitivity (balloon inflation) and anthropometric measurements	1 hour

Collaborators and Investigators

• Sponsor: University of Zurich

Publications and helpful links

General Publications

• Ang D, Misselwitz B, Hollenstein M, Knowles K, Wright J, Tucker E, Sweis R, Fox M. Diagnostic yield of high-resolution manometry with a solid test meal for clinically relevant, symptomatic oesophageal motility disorders: serial diagnostic study. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):654-661. doi: 10.1016/S2468-1253(17)30148-6. Epub 2017 Jul 3.
• Hollenstein M, Thwaites P, Butikofer S, Heinrich H, Sauter M, Ulmer I, Pohl D, Ang D, Eberli D, Schwizer W, Fried M, Distler O, Fox M, Misselwitz B. Pharyngeal swallowing and oesophageal motility during a solid meal test: a prospective study in healthy volunteers and patients with major motility disorders. Lancet Gastroenterol Hepatol. 2017 Sep;2(9):644-653. doi: 10.1016/S2468-1253(17)30151-6. Epub 2017 Jul 3.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Diaphragmatic; Internal Hernia; Hernia; Hernia, Hiatal
• Other Study ID Numbers: KEK-ZH-Nr. 2014-0013