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

NCT ID: NCT04988438

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-15

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Motility Disorder

Keywords

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After COVID-19 gastrointestinal motility

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Dubrava

OTHER

Sponsor Role lead

Responsible Party

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Žarko Babić

Principal investigator, Clinical professor, Heat of Interventional gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Žarko B Babić, prof.dr.sc.

Role: PRINCIPAL_INVESTIGATOR

Head od Interventional gastroenterology UH Dubrava

Locations

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Prof.dr.sc. Žarko Babić, FEBGH

Zagreb, Select State, Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Žarko Babić, prof.dr.sc.

Role: CONTACT

Phone: +38512903390

Email: [email protected]

Marko Banić, prof.dr.sc.

Role: CONTACT

Phone: +38512903390

Email: [email protected]

Facility Contacts

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Žarko Babić, prof.

Role: primary

Other Identifiers

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2021/1407-03UHD

Identifier Type: -

Identifier Source: org_study_id