Clinical trial NCT04988438: Gastrointestinal Motor Disorders (Esophageal and Anorectal) After COVID-19
Official title: Gastrointestinal Motor Disorders (Esophageal and Anorectal) in Patients After COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Motility Disorder
Keywords: After COVID-19
gastrointestinal motility
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients from 20-80 years, men and women.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of esophageal parameters 1 on manometry
timeFrame: 120 days
measure: Measurement of esophageal parameters 2 on manometry
timeFrame: 120 days
measure: Measurement of esophageal parameters 3 on manometry
timeFrame: 120 days
measure: Measurement of esophageal parameters 4 on manometry
timeFrame: 120 days
measure: Measurement of esophageal parameters 5 on manometry
timeFrame: 120 days
measure: Measurement of esophageal parameters 6 on manometry
timeFrame: 120 days
measure: Measurement of anorectal parameters 1 on manometry
timeFrame: 2 years
measure: Measurement of anorectal parameters 2 on manometry
timeFrame: 2 years
measure: Measurement of anorectal parameters 3 on manometry
timeFrame: 2 years
measure: Measurement of anorectal parameters 4 on manometry
timeFrame: 2 years
measure: Measurement of anorectal parameters 5 on manometry
timeFrame: 2 years
measure: Measurement of anorectal parameters 6 on manometry
timeFrame: 2 years
measure: Measurement of anorectal parameters 7 on manometry
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Prof.dr.sc. Žarko Babić, FEBGH
state: Select State
Study officials:
affiliation: Head od Interventional gastroenterology UH Dubrava
name: Žarko B Babić, prof.dr.sc.
role: PRINCIPAL_INVESTIGATOR
References: