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

Gastrointestinal Motility Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04988438
• Other study ID #: 2021/1407-03UHD
• Status: Recruiting
• Start date: August 15, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2021
• Source: University Hospital Dubrava
• Contact: Žarko Babic, prof.dr.sc.
• Phone: +38512903390
• Email: zarko.babic[@]zg.t-com.hr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2023
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Gastrointestinal Motility Disorder
• Motor Disorders

Locations

Country	Name	City	State
Croatia	Prof.dr.sc. Žarko Babic, FEBGH	Zagreb	Select State

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

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