Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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)
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
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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