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

• Conditions: Gastrointestinal Motility Disorder

• Registration Number: NCT04988438
• Lead Sponsor: University Hospital Dubrava

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-03
• Study Start: 2021-08-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Primary Completion: 2021-09-30
• Last Update Posted: 2021-09-30
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Prof.dr.sc. Žarko Babić, FEBGH; 🇭🇷 Zagreb, Select State, Croatia