Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis

• Conditions: Chronic Rhinosinusitis

• Registration Number: NCT00899561
• Lead Sponsor: Meir Medical Center

Brief Summary

In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group.

The investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Primary Completion: 2010-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-19
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adult patients with chronic rhinosinusitis who failed conservative medical treatment,
• Patients who stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.

Exclusion Criteria

• Immunosuppressed patients,
• Patients in whom no indication to excise the middle turbinate was found, AND
• Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inflammation of soft tissue and bony elements of the middle turbinate	two years

Secondary Outcome Measures

Name	Time	Method
correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis	two years

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel