The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis

Rhinosinusitis Clinical Trial

Official title:

New Insights on the Clinical Significance of the Uncinate Process Histopathology in Patients With Chronic Rhinosinusitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01296919
• Other study ID #: AssutaHS10-2010037
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2011
• Last updated: September 11, 2011
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: February 2011
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.

Description:

The purpose of the present study is to gain insight into the histopathological changes of the uncinate process in patients with chronic rhinosinusitis through comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with chronic rhinosinusitis who:

• Failed conservative medical treatment.

• Stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.

• Had a Lund-MacKay CT score of 2 and higher of 24 available.

Exclusion Criteria:

• Immunosuppressed patients.

• Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).

• Patients with a Lund-MacKay CT score < 2 of 24 available.

• Pregnant women.

• Patients who underwent prior endoscopic sinus surgery.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinosinusitis
• Sinusitis

Locations

Country	Name	City	State
Israel	AssutaHS	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel,