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CompletedNCT02397616Updated Jul 3, 2018

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

An observational study in Hiatus Hernia, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
380
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Hiatus Hernia

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03

In context

Hernia, Hiatal

86 studies on the registry are indexed under Hernia, Hiatal; 28 are open to participants now.

This study's enrollment of 380 is above the median of 107 across 28 observational studies indexed under Hernia, Hiatal.

Browse Hernia, Hiatal studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
380 participants (actual)
Patient registry
No

Interventions

  • Otherhigh resolution esophageal manometry

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

06

What researchers measure

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

07

Study locations

1 site
  • Division of Gastroenterology, University Hospital Zurich
    Zurich, 8091, Switzerland
08

References and documents

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. PubMed 28684262 ↗
  • 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. PubMed 28684261 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02397616
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Mar 25, 2015
Start date
Jan 2015
Primary completion
Dec 1, 2017
Completion
Dec 1, 2017
Last update
Jul 3, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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