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Clinical Trials/NCT00899561
NCT00899561
Unknown
Not Applicable

Correlation Between Middle Turbinate Histopathology and Computed Tomography Staging in Chronic Rhinosinusitis

Meir Medical Center1 site in 1 country45 target enrollmentDecember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Rhinosinusitis
Sponsor
Meir Medical Center
Enrollment
45
Locations
1
Primary Endpoint
inflammation of soft tissue and bony elements of the middle turbinate
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
December 2012
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

inflammation of soft tissue and bony elements of the middle turbinate

Time Frame: two years

Secondary Outcomes

  • correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis(two years)

Study Sites (1)

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