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

U

University Hospital Dubrava

Status

Unknown

Conditions

Gastrointestinal Motility Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT04988438
2021/1407-03UHD

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

esophageal manometry
Description:
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
Description:
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).

Trial contacts and locations

1

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Central trial contact

Marko Banić, prof.dr.sc.; Žarko Babić, prof.dr.sc.

Data sourced from clinicaltrials.gov

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