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Diagnostics of Mycotic Sinusitis in ENT Patients

Primary Purpose

Fungal Sinusitis

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Samplings from patient's affected paranasal sinus
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fungal Sinusitis focused on measuring Sinusitis, Mycosis, Paranasal sinus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ostrava, Department of Otorhinolaryngology and Head and Neck SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with clinical suspicion of mycotic sinusitis

Arm Description

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

Outcomes

Primary Outcome Measures

Computer tomography (CT) examination of the paranasal sinuses - images
Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.
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.
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.
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.
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.
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).
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.
Entrance ENT examination - olfactory questionnaire
Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.
Entrance ENT examination - without endoscope
Observation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.
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.
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.
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.
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.
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.
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.
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.
Postoperative sample analysis - culture examination of sample 3
Evaluation of the cultured finding will be done by a microbiologist.
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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2023
Last Updated
July 24, 2023
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT05955859
Brief Title
Diagnostics of Mycotic Sinusitis in ENT Patients
Official Title
Diagnostics of Mycotic Sinusitis in Patients With Unilateral Obfuscation of the Paranasal Sinus and Patients With Uni-lateral Discharge From the Nasal Cavity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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 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 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 . 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Sinusitis
Keywords
Sinusitis, Mycosis, Paranasal sinus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with clinical suspicion of mycotic sinusitis
Arm Type
Experimental
Arm Description
Patient with clinical suspicion of mycotic sinusitis will undergo an examination as listed in Detailed Description.
Intervention Type
Procedure
Intervention Name(s)
Samplings from patient's affected paranasal sinus
Intervention Description
Samplings from patient's affected paranasal sinus during endoscopic surgery.
Primary Outcome Measure Information:
Title
Computer tomography (CT) examination of the paranasal sinuses - images
Description
Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.
Time Frame
3 years
Title
Computer tomography (CT) examination of the paranasal sinuses - criteria
Description
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
Title
Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses
Description
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
Title
Entrance ENT examination - anamnesis
Description
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
Title
Entrance ENT examination - SNOT-22
Description
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
Title
Entrance ENT examination - rhinoVAS
Description
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
Title
Entrance ENT examination - NOSE score
Description
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
Title
Entrance ENT examination - olfactory questionnaire
Description
Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.
Time Frame
3 years
Title
Entrance ENT examination - without endoscope
Description
Observation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.
Time Frame
3 years
Title
Entrance ENT examination - endoscopic examination
Description
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
Title
Functional endonasal endoscopic surgery (FESS) - sample 1
Description
Mycotic material (as sample 1) for histological examination will be taken from patient´s affected cavity during FESS.
Time Frame
3 years
Title
Functional endonasal endoscopic surgery (FESS) - sample 2
Description
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
Title
Functional endonasal endoscopic surgery (FESS) - sample 3
Description
Mycotic material for culture examination of fungi (as sample 3) will be taken from patient´s affected cavity during FESS.
Time Frame
3 years
Title
Functional endonasal endoscopic surgery (FESS) - sample 4
Description
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
Title
Postoperative sample analysis - histological examination of sample 1
Description
Evaluation of the sample 1 (mycotic material) will be done to find out the presence of hyphae, inflammatory cellulization, calcification.
Time Frame
3 years
Title
Postoperative sample analysis - histological examination of sample 2
Description
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
Title
Postoperative sample analysis - culture examination of sample 3
Description
Evaluation of the cultured finding will be done by a microbiologist.
Time Frame
3 years
Title
Postoperative sample analysis - elemental analysis of sample 4
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Polášková, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petr Matoušek, MD, Ph.D.
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michaela Masárová, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pavel Komínek, Prof., MD, Ph.D.
Organizational Affiliation
University Hospital Ostrava
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Ostrava, Department of Otorhinolaryngology and Head and Neck Surgery
City
Ostrava
State/Province
Czech Republic
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Simona Polášková, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data with other researchers.

Learn more about this trial

Diagnostics of Mycotic Sinusitis in ENT Patients

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