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

NCT02397616 — Completed, 380 participants, University of Zurich

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RegistryNCT02397616
StatusCompleted
Study typeObservational
Enrollment380 (Actual)
SponsorUniversity of Zurich (Other)
ConditionsHiatus Hernia
Interventionshigh resolution esophageal manometry (Other)
Datesstart 2015-01-01, primary completion 2017-12-01, completion 2017-12-01, first posted 2015-03-25, last updated 2018-07-03
Locations1 site in Switzerland

Related Papers Related Patents Related Grants Related Experts
All trials for Hiatus Hernia All trials of high resolution esophageal manometry

-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.

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

  • Effects of hernia type (consistent hernia, transient hernia and no hernia, as specified bellow) on reflux symptoms [1 months]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Division of Gastroenterology, University Hospital ZurichZurichSwitzerland

+Publications

  • Results publication: 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. PMID 28684262
  • Results publication: 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. PMID 28684261