Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis .

Allergic Fungal Rhinosinusitis Clinical Trial

Official title:

Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376071
• Other study ID #: fungal rhinosiusitis
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: khater nosir sayed, master
• Phone: 01011973180
• Email: khatrsnyr289[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::

1. anatomical variations and correlate radiological finding with intraoperative finding.

2. other associated factors like demographic ,environmental, immunological and climatic risk factors .

Description:

Introduction Allergic fungal rhinosinusitis (AFRS) is a subtype of CRS with nasal polyposis (CRSwNP) that is characterized by eosinophilic mucin within expanded sinus cavities and immunoglobulin E (IgE)-mediated type 1 hypersensitivity to fungal elements. This noninvasive disease process typically affects immunocompetent, younger patients in geographic regions with warm temperatures and high humidity, which facilitate fungal proliferation.

AFRS has a worldwide distribution pattern with varying prevalence. AFRS is presented in variable rates in different climatic, socioeconomic, and geographic factors. The disease prevalence showed predilection toward climatic factors

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: June 30, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

Denovo cases . any Age Any sex. Patients diagnosed with unilateral or bilateral allergic fungal rhino sinusitis, meeting classic Bent and Kuhn criteria for AFRS:(10).

Nasal polyposis. Fungi on staining. Eosinophilic mucin without fungal invasion into sinus tissue., Type I hypersensitivity to fungi. Characteristic radiologic findings with soft-tissue differential densities on computed tomographic (CT) scanning

Exclusion criteria:

Diagnosis of benign or malignant neoplasm of the sinonasal cavity. Prior radiation therapy to the head or neck. Significant prior facial trauma. Autoimmune disorder. Craniofacial anomaly. Fungus ball. Immunodeficiency. Cystic fibrosis. Patients unfit for surgery. Previous nasal surgery or recurrent cases .

Related Conditions & MeSH terms

• Allergic Fungal Rhinosinusitis
• Allergic Fungal Sinusitis
• Rhinosinusitis
• Sinusitis

Intervention

Diagnostic Test:
• functional endoscopic sinus surgery
functional endoscopic sinus surgery for diagnosis the disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Akhondi H, Woldemariam B, Rajasurya V. Fungal Sinusitis. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551496/ — View Citation

Kwon E, O'Rourke MC. Chronic Sinusitis. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441934/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis	analysis of the risk factors of unilateral versus bilateral allergic fungal rhinosinusitis	baseline

External Links

•   Indian J Otolaryngol Head Neck Surg. 2023 Jun;75(2):571-578. doi: 10.1007/s12070-022-03338-0. Epub 2022 Dec 17