Gastrointestinal Motor Disorders (Esophageal and Anorectal) After COVID-19
1 other identifier
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedStudy Start
First participant enrolled
August 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedSeptember 30, 2021
September 1, 2021
2 months
July 27, 2021
September 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Measurement of esophageal parameters 1 on manometry
In esophagus we will measure Upper and lower esophageal sphincter pressure in mmHg.
120 days
Measurement of esophageal parameters 2 on manometry
In esophagus we will measure Integrated relaxation pressure (IRP) in mmHg.
120 days
Measurement of esophageal parameters 3 on manometry
In esophagus we will measure Contractile front velocity (CVF) in cm/s.
120 days
Measurement of esophageal parameters 4 on manometry
In esophagus we will measure Distal contractile integral (DCI) in mmHg.s.cm.
120 days
Measurement of esophageal parameters 5 on manometry
In esophagus we will measure Distal latency (DL) in seconds.
120 days
Measurement of esophageal parameters 6 on manometry
In esophagus we will measure Peristaltic brake (BR) in cm.
120 days
Measurement of anorectal parameters 1 on manometry
On anorectal manometry we will measure Resting test pressure in mmHg.
2 years
Measurement of anorectal parameters 2 on manometry
On anorectal manometry we will measure Squeeze test pressure in mmHg.
2 years
Measurement of anorectal parameters 3 on manometry
On anorectal manometry we will measure Endurance squeeze test pressure in mmHg.
2 years
Measurement of anorectal parameters 4 on manometry
On anorectal manometry we will measure recto-anal inhibitory reflex test (RAIR)- relaxation in percent.
2 years
Measurement of anorectal parameters 5 on manometry
On anorectal manometry we will measure Push test pressure in mmHg.
2 years
Measurement of anorectal parameters 6 on manometry
On anorectal manometry we will measure Sensation test with ml in balloon.
2 years
Measurement of anorectal parameters 7 on manometry
On anorectal manometry we will measure Balloon expulsion test as positive or negative.
2 years
Study Arms (2)
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).
Eligibility Criteria
The patients from 20-80 years, men and women.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prof.dr.sc. Žarko Babić, FEBGH
Zagreb, Select State, 10000, Croatia
Related Publications (1)
Babic Z, Bezdrov L, Haber VE, Kardum D, Andabak M, Rob Z, Banic M. Esophageal motility disorders after COVID-19 infection. Sci Rep. 2025 Dec 6;16(1):1428. doi: 10.1038/s41598-025-31067-1.
PMID: 41353487DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Žarko B Babić, prof.dr.sc.
Head od Interventional gastroenterology UH Dubrava
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, Clinical professor, Heat of Interventional gastroenterology
Study Record Dates
First Submitted
July 27, 2021
First Posted
August 3, 2021
Study Start
August 15, 2021
Primary Completion
September 30, 2021
Study Completion
August 31, 2023
Last Updated
September 30, 2021
Record last verified: 2021-09