Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05955859

Diagnostics of Mycotic Sinusitis in Patients With Unilateral Obfuscation of the Paranasal Sinus and Patients With Uni-lateral Discharge From the Nasal Cavity

Led by University Hospital Ostrava · Updated on 2023-07-27

65

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Mycotic sinusitis is a rare inflammatory condition affecting the paranasal sinuses, with rising cases in recent years. It includes non-invasive forms such as mycetoma and allergic mycotic sinusitis, often involving the maxillary sinus. Diagnosing this fungal sinusitis is challenging due to nonspecific symptoms like nasal obstruction and pain, and sometimes patients have no symptoms. Improving diagnosis is important as current methods rely on clinical signs, endoscopic findings, and CT scans, which have limitations in specificity. Patients with suspected mycotic sinusitis will undergo a detailed series of examinations. These include an ear, nose, and throat (ENT) assessment with questionnaires and endoscopic examination, a CT scan of the paranasal sinuses to evaluate sinus conditions and anatomical features, and functional endonasal endoscopic surgery (FESS) to clean the affected sinus and collect samples. Collected samples will be analyzed through histological, culture, and elemental examinations to identify fungal involvement. During the study, participants will have multiple assessments including clinical history, symptom questionnaires, nasal endoscopy, CT imaging, and surgery if needed. Samples taken during surgery will be examined for fungal presence and tissue changes. The study will follow participants for up to three years, monitoring CT scan changes, clinical symptoms, and laboratory results to better understand diagnostic signs of mycotic sinusitis. This comprehensive approach aims to improve detection and characterization of this condition.

CONDITIONS

Brief Title

Diagnostics of Mycotic Sinusitis in ENT Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients with blockage or discharge from only one side of the paranasal sinus or nasal cavity
Not Eligible

You will not qualify if you...

  • Serious illness in decompensation phase such as cardiac, liver, kidney disease, or cancer
  • Serious psychiatric illnesses
  • Pregnancy
  • High operative risk classified as ASA IV or higher
  • Disagreement with participation in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants undergo a series of examinations including ENT assessments and computed tomography (CT) scans to identify signs of fungal sinusitis.

1 to 2 visits (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants receive functional endonasal endoscopic surgery (FESS) to clean the affected sinus cavity and collect samples for analysis.

1 surgical visit (in-person)

Postoperative Follow-up

Duration - Approximately 2 weeks

Participants' collected samples undergo histological, culture, and elemental analyses to evaluate fungal infection and inflammation.

1 to 2 follow-up visits (in-person)

Trial Site Locations

Total: 1 location

1

University Hospital Ostrava, Department of Otorhinolaryngology and Head and Neck Surgery

Ostrava, Czech Republic, Czechia, 70852

Actively Recruiting

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Research Team

J

Jiří Hynčica

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Frequently Asked Questions

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