An interventional study of Samplings from patient's affected paranasal sinus in Fungal Sinusitis, sponsored by University Hospital Ostrava. Recruiting at 1 site in Czechia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Diagnostic
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.
To identify specific determining signs for the diagnosis of fungal sinusitis, patients will undergo a series of examinations listed below.
Entrance ear, nose, throat (ENT) examination
Computed tomography (CT) examination of the paranasal sinuses
Functional endonasal endoscopic surgery (FESS)
postoperative sample analysis
Exclusion Criteria:
Patient with clinical suspicion of mycotic sinusitis will undergo an examination as listed in Detailed Description.
Procedure: Samplings from patient's affected paranasal sinus
Samplings from patient's affected paranasal sinus during endoscopic surgery.
Computer tomography (CT) examination of the paranasal sinuses - images
Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.
Time frame: 3 years
Computer tomography (CT) examination of the paranasal sinuses - criteria
Evaluation 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.
Time frame: 3 years
Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses
Evaluation 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.
Time frame: 3 years
Entrance ENT examination - anamnesis
Taking anamnesis from patients to summarize any nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw or immune disorder.
Time frame: 3 years
Entrance ENT examination - SNOT-22
Sino-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.
Time frame: 3 years
Entrance ENT examination - rhinoVAS
Rhino 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).
Time frame: 3 years
Entrance ENT examination - NOSE score
A 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.
Time frame: 3 years
Entrance ENT examination - olfactory questionnaire
Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.
Time frame: 3 years
Entrance ENT examination - without endoscope
Observation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.
Time frame: 3 years
Entrance ENT examination - endoscopic examination
Endoscopic 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.
Time frame: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 1
Mycotic material (as sample 1) for histological examination will be taken from patient´s affected cavity during FESS.
Time frame: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 2
Mucous of the affected paranasal sinus (as sample 2) for histological examination will be taken from patient´s affected cavity during FESS.
Time frame: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 3
Mycotic material for culture examination of fungi (as sample 3) will be taken from patient´s affected cavity during FESS.
Time frame: 3 years
Functional endonasal endoscopic surgery (FESS) - sample 4
Mycotic material for elemental analysis using electron microscopy (as sample 4) will be taken from patient´s affected cavity during FESS.
Time frame: 3 years
Postoperative sample analysis - histological examination of sample 1
Evaluation of the sample 1 (mycotic material) will be done to find out the presence of hyphae, inflammatory cellulization, calcification.
Time frame: 3 years
Postoperative sample analysis - histological examination of sample 2
Evaluation 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.
Time frame: 3 years
Postoperative sample analysis - culture examination of sample 3
Evaluation of the cultured finding will be done by a microbiologist.
Time frame: 3 years
Postoperative sample analysis - elemental analysis of sample 4
Control 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.
Time frame: 3 years
Plan to share: No — There is no plan to share individual participant data with other researchers.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Ostrava