Complicated Rhinosinusitis

September 18, 2024 updated by: Fatma Abd El_Atty Sayed Harb, Assiut University

Anatomical Risk Factors for Orbital Complications in Patients With Acute Rhinosinusitis

Rhinosinusitis is among the most common conditions encountered in the primary care clinic.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

serious sequelae of ARS, including orbital and intracranial complications as Like Periorbital oedema and Displaced globe and Double vision and Ophthalmoplegia Reduced visual acuity

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

OBSERVATIONAL Split-half case-comparison study.

Description

Inclusion Criteria:

  • Patients with orbital complications of rhinosinusitis

Exclusion Criteria:

  • 1- Previous maxillofacial trauma history. 2- Previous nasal or paranasal surgery. 3- Invasive fungal rhinosinusitis. 4- Cases with odontogenic rhinosinusitis. 5- Immotile cilia syndrome, cystic fibrosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orbital complications of rhinosinusitis
Time Frame: One year
The presence of agger nasi cells (AGC), concha bullosa, Haller, Onodi or frontal recess cells, septal deviation, lower turbinate hypertrophy and hypoplasia or agenesis of the PNS
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed Abdelaziz, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Orbital complications of AR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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