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Diagnostics of Mycotic Sinusitis in ENT Patients

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05955859
Enrollment
65
Registered
2023-07-21
Start date
2023-05-02
Completion date
2026-12-31
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Sinusitis

Keywords

Sinusitis, Mycosis, Paranasal sinus

Brief summary

Mycotic sinusitis is a rare inflammatory disease of the paranasal sinuses. In recent years, its occurrence is increasing. Due to this situation, mycotic sinusitis is gaining importance, even though most cases of mycotic sinusitis are limited on paranasal sinuses. Non-invasive forms of mycotic sinusitis are divided into mycetoma and allergic mycotic sinusitis. Mycetoma (fungus ball) usually affects only one paranasal sinus, most often maxillary sinus. The predisposing factors which participate on development of mycotic sinusitis are not exactly known. Some factors are considered as possible predisposing factors, for example deviation of nasal septum, dental treatment of upper jaw teeth or changes of nasal microbiome. The diagnosis of fungal sinusitis is problematic. With the increasing number of patients, it is essential to improve the diagnostic process. In present, suspicion of mycotic sinusitis is based on the patient's clinical symptoms and the endoscopic findings in the nasal cavity. Only in some cases nonspecific findings can be observed, such as smelly secretions from the nose, feeling of stuffy nose and pain over the affected sinus. Some patients may be completely asymptomatic, and only in some cases fungal masses can be observed in the nasal cavity. Computed tomography (CT) scans are gaining more and more importance. Typical sign of an affected sinus is obfuscation on CT scan but this sign is not specific for mycotic infection. Central hyperdense foci are also present in some patients, but they are also not specific and can imitate a foreign body. Identifying specific signs on CT scan could help with diagnosing mycotic sinusitis.

Detailed description

To identify specific determining signs for the diagnosis of fungal sinusitis, patients will undergo a series of examinations listed below. 1. Entrance ear, nose, throat (ENT) examination * anamnesis (nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw, immune disorder) * rhinological questionnaires (SNOT-22, rhinoVAS, NOSE score, olfactory questionnaire) * ENT examination without endoscope: deviation of the nasal septum or hypertrophy of the nasal conchae, pathological secretion from the nose * endoscopic examination of the nose: pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum 2. Computed tomography (CT) examination of the paranasal sinuses * evaluation of images in the frontal, sagittal and transverse planes * criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses * anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus 3. Functional endonasal endoscopic surgery (FESS) * method of execution performance of functional endonasal endoscopic surgery - only the affected cavity is being operated, complete cleaning of the affected cavity * sampling during surgery (4 in total): two samples for histological examination (sample 1 - mycotic material, sample 2 - mucous of the affected paranasal sinus), sample 3 - mycotic material for culture examination of fungi, sample 4 - mycotic material for elemental analysis using electron microscopy . 4. postoperative sample analysis * elemental analysis (sample 4): before analysis - control X-ray examination of the sample, the presence of hyperdense material on the X-ray image, performing electron microscopy, according to the structure of element evaluation. * histological examination (sample 1 and 2): evaluation of the sample 2 - mucosa of the paranasal sinuses - the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa, evaluation of the sample 1 (mycotic material) - the presence of hyphae, inflammatory cellulization, calcification. * culture examination (sample 3): evaluation of the cultured finding by a microbiologist

Interventions

PROCEDURESamplings from patient's affected paranasal sinus

Samplings from patient's affected paranasal sinus during endoscopic surgery.

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age ≥ 18 years * patients with unilateral obfuscation of the paranasal sinus and patients with unilateral discharge from the nasal cavity

Exclusion criteria

* serious illness (decompensation phase) - cardiac, liver, kidney disease, can-cer * serious psychiatric illnesses * pregnancy * high operative risk according to The American Society of Anesthesiologists (ASA) ≥ IV * disagreement with participation in the study

Design outcomes

Primary

MeasureTime frameDescription
Entrance ENT examination - without endoscope3 yearsObservation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.
Computer tomography (CT) examination of the paranasal sinuses - images3 yearsEvaluation of images in the frontal, sagittal and transverse planes - condition assessment.
Computer tomography (CT) examination of the paranasal sinuses - criteria3 yearsEvaluation of criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses.
Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses3 yearsEvaluation of anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus.
Entrance ENT examination - anamnesis3 yearsTaking anamnesis from patients to summarize any nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw or immune disorder.
Entrance ENT examination - SNOT-223 yearsSino-Nasal Outcome Test-22 (SNOT-22) Questionnaire - The patients will complete a list of symptoms and social/emotional consequences of their nasal disorder. The SNOT-22 is a validated scale that measures sinonasal symptoms in patients with sinusitis. The 22 questions are scored on a scale of 0-5 with a maximum total score of 110. Higher scores represent more symptomatic patients.
Entrance ENT examination - rhinoVAS3 yearsRhino Visual Analogue Scale (RhinoVAS) questionnaire will be used to assess postoperative changes in nasal function ranging from 0 (complete nose patency) to 10 cm (complete nose obstruction).
Entrance ENT examination - NOSE score3 yearsA simple, five-question, validated Nasal Obstruction Symptom Evaluation (NOSE) instrument that uses a 20-point scale to capture breathing symptoms, with higher scores indicating more severe symptoms than lower scores. A score of 0 means no problems with nasal obstruction and a score of 100 means the worst possible problems with nasal obstruction.
Entrance ENT examination - olfactory questionnaire3 yearsOlfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.
Entrance ENT examination - endoscopic examination3 yearsEndoscopic examination of the nose in order to find any pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum.
Functional endonasal endoscopic surgery (FESS) - sample 13 yearsMycotic material (as sample 1) for histological examination will be taken from patient´s affected cavity during FESS.
Functional endonasal endoscopic surgery (FESS) - sample 23 yearsMucous of the affected paranasal sinus (as sample 2) for histological examination will be taken from patient´s affected cavity during FESS.
Functional endonasal endoscopic surgery (FESS) - sample 33 yearsMycotic material for culture examination of fungi (as sample 3) will be taken from patient´s affected cavity during FESS.
Functional endonasal endoscopic surgery (FESS) - sample 43 yearsMycotic material for elemental analysis using electron microscopy (as sample 4) will be taken from patient´s affected cavity during FESS.
Postoperative sample analysis - histological examination of sample 13 yearsEvaluation of the sample 1 (mycotic material) will be done to find out the presence of hyphae, inflammatory cellulization, calcification.
Postoperative sample analysis - histological examination of sample 23 yearsEvaluation of the sample 2 (mucosa of the paranasal sinuses) will be done to find out the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa.
Postoperative sample analysis - culture examination of sample 33 yearsEvaluation of the cultured finding will be done by a microbiologist.
Postoperative sample analysis - elemental analysis of sample 43 yearsControl X-ray examination of the sample will be taken before analysis to find out the presence of hyperdense material on the X-ray image. Performing electron microscopy, according to the structure of ele-ment evaluation.

Countries

Czechia

Contacts

Primary ContactJiří Hynčica
jiri.hyncica@fno.cz0042059737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026