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

Chronic Rhinosinusitis Clinical Trial

— CT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00899561
• Other study ID #: MeirMc
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2009
• Last updated: March 16, 2012
• Start date: December 2008
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Gilead Berger, MD
• Email: berger45[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Meir Medical Center	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammation of soft tissue and bony elements of the middle turbinate		two years	No
Secondary	correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis		two years	No