Diagnostics of Mycotic Sinusitis in ENT Patients

NCT05955859 | Recruiting

• 2 other identifiers: KORLCHHK-2023-Mycosis06-RVO-FNOs/2023
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Fungal Sinusitis

Keywords

Sinusitis; Mycosis; Paranasal sinus

Outcome Measures

Primary Outcomes (18)

• Computer tomography (CT) examination of the paranasal sinuses - images

  Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.

  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.

  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.

  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.

  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.

  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).

  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.

  3 years

• Entrance ENT examination - olfactory questionnaire

  Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  3 years

• Postoperative sample analysis - culture examination of sample 3

  Evaluation of the cultured finding will be done by a microbiologist.

  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.

  3 years

Study Arms (1)

Patient with clinical suspicion of mycotic sinusitis

EXPERIMENTAL

Patient with clinical suspicion of mycotic sinusitis will undergo an examination as listed in Detailed Description.

Procedure: Samplings from patient's affected paranasal sinus

Interventions

Samplings from patient's affected paranasal sinus PROCEDURE

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

Patient with clinical suspicion of mycotic sinusitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

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

Ostrava, Czech Republic, 70852, Czechia

RECRUITING

MeSH Terms

Conditions

Sinusitis; Mycoses

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bacterial Infections and Mycoses

Study Officials

• Simona Polášková, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

• Petr Matoušek, MD, Ph.D.

  University Hospital Ostrava

  STUDY CHAIR

• Michaela Masárová, MD

  University Hospital Ostrava

  STUDY CHAIR

• Pavel Komínek, Prof., MD, Ph.D.

  University Hospital Ostrava

  STUDY CHAIR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: May 2, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)