Gastrointestinal Motor Disorders (Esophageal and Anorectal) After COVID-19

September 29, 2021 updated by: Žarko Babić, University Hospital Dubrava

Gastrointestinal Motor Disorders (Esophageal and Anorectal) in Patients After COVID-19 Infection

The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal disorder (esophageal and anorectal) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The patients who had COVID-19 infection, and after that reported for one of the signs of gastrointestinal (esophageal and anorectal disorder) will be underwent to esophageal and anorectal motor monitoring investigation (HRM manometry) on standard protocol.

The patients with dysphagia, chest discomfort during swallowing, or chest pain during swallowing, patients with obstipation, fecal evacuation symptoms, lower stomach discomfort before defecation etc. will be included in the study. In all of them other gastrointestinal diseases will be excluded by standard routine laboratory investigation, ultrasound, routine endoscopy investigation and 24 hours impedance pH-measurement.

After manometric measurement of esophagus and anorectal region to standard protocol by using MMS-HRM 360 monitoring system with 36 canals catheter for esophagus and 24 canals catheter for anorectal monitoring, data will be calculated by using statistics.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Marko Banić, prof.dr.sc.
  • Phone Number: +38512903390
  • Email: mbanic@kbd.hr

Study Locations

  • Croatia
    • Select State
      • Zagreb, Select State, Croatia, 10000
        • Recruiting
        • Prof.dr.sc. Žarko Babić, FEBGH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients from 20-80 years, men and women.

Description

Inclusion Criteria:

  • Patients with esophageal and anorectal symptoms after COVID 19- infection
  • Patients with worsening of esophageal and anorectal symptom after COVID 19- infection, but who had previously described esophageal and anorectal symptoms

Exclusion Criteria:

  • Other gastrointestinal disease that can influence to results
  • Gastroesophageal reflux
  • H. Pylori infection
  • Bacterial, parasitic, viral and fungal gastrointestinal infection or infestation
  • Myasthenia
  • Scleroderma
  • Diabetes mellitus
  • Thyroidal hyperfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
esophageal manometry

The patients who has previously mentioned symptoms will underwent to manometry monitoring of esophageal and anorectal disorders.

For this investigation we have proven normal and standardized manometric values on previous investigations by other authors, so the control group is not needed. We know the normal manometric values (Chicago 3 score).
anorectal manometry

The patients who has previously mentioned symptoms will underwent to manometry monitoring of esophageal and anorectal disorders.

For this investigation we have proven normal and standardized manometric values on previous investigations by other authors, so the control group is not needed. We know the normal manometric values (London protocol).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of esophageal parameters 1 on manometry
Time Frame: 120 days
In esophagus we will measure Upper and lower esophageal sphincter pressure in mmHg.
120 days
Measurement of esophageal parameters 2 on manometry
Time Frame: 120 days
In esophagus we will measure Integrated relaxation pressure (IRP) in mmHg.
120 days
Measurement of esophageal parameters 3 on manometry
Time Frame: 120 days
In esophagus we will measure Contractile front velocity (CVF) in cm/s.
120 days
Measurement of esophageal parameters 4 on manometry
Time Frame: 120 days
In esophagus we will measure Distal contractile integral (DCI) in mmHg.s.cm.
120 days
Measurement of esophageal parameters 5 on manometry
Time Frame: 120 days
In esophagus we will measure Distal latency (DL) in seconds.
120 days
Measurement of esophageal parameters 6 on manometry
Time Frame: 120 days
In esophagus we will measure Peristaltic brake (BR) in cm.
120 days
Measurement of anorectal parameters 1 on manometry
Time Frame: 2 years
On anorectal manometry we will measure Resting test pressure in mmHg.
2 years
Measurement of anorectal parameters 2 on manometry
Time Frame: 2 years
On anorectal manometry we will measure Squeeze test pressure in mmHg.
2 years
Measurement of anorectal parameters 3 on manometry
Time Frame: 2 years
On anorectal manometry we will measure Endurance squeeze test pressure in mmHg.
2 years
Measurement of anorectal parameters 4 on manometry
Time Frame: 2 years
On anorectal manometry we will measure recto-anal inhibitory reflex test (RAIR)- relaxation in percent.
2 years
Measurement of anorectal parameters 5 on manometry
Time Frame: 2 years
On anorectal manometry we will measure Push test pressure in mmHg.
2 years
Measurement of anorectal parameters 6 on manometry
Time Frame: 2 years
On anorectal manometry we will measure Sensation test with ml in balloon.
2 years
Measurement of anorectal parameters 7 on manometry
Time Frame: 2 years
On anorectal manometry we will measure Balloon expulsion test as positive or negative.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Dubrava

Investigators

  • Principal Investigator: Žarko B Babić, prof.dr.sc., Head od Interventional gastroenterology UH Dubrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/1407-03UHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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