NCT06376071

Brief Summary

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

  1. 1.anatomical variations and correlate radiological finding with intraoperative finding.
  2. 2.other associated factors like demographic ,environmental, immunological and climatic risk factors .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 17, 2024

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

functional endoscopic sinus surgery for diagnosis the disease

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be divided into two groups: Group (A): including patients with unilateral allergic fungal rhinosinusitis. Group (B): including patients with bilateral allergic fungal rhinosinusitis. Then all patient will subjected to EFSS under general anathesia with wide sinusotomics where intraoperative collection of data will be done as the follow

You may qualify if:

  • 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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kwon E, O'Rourke MC. Chronic Sinusitis. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441934/

    PMID: 28722963BACKGROUND
  • Akhondi H, Woldemariam B, Rajasurya V. Fungal Sinusitis. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551496/

Related Links

MeSH Terms

Conditions

Allergic Fungal Sinusitis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

khater nosir sayed, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 19, 2024

Study Start

May 1, 2024

Primary Completion

May 1, 2025

Study Completion

June 30, 2025

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share