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

NCT ID: NCT00899561

Last Updated: 2012-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Chronic Rhinosinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role collaborator

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Berger, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Roee Landsberg, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gilead Berger, MD

Role: CONTACT

Facility Contacts

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Gilead Berger, MD

Role: primary

Other Identifiers

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MeirMc

Identifier Type: -

Identifier Source: org_study_id

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