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

NCT02397616 | Completed

• 1 other identifier: KEK-ZH-Nr. 2014-0013
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiatus Hernia

Outcome Measures

Primary Outcomes (1)

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

  1 months

Secondary Outcomes (8)

• 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

Interventions

high resolution esophageal manometry OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Hernia, Hiatal

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 25, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

CH (1)