The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assuta Hospital Systems.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT01296919
First received: February 14, 2011
Last updated: September 11, 2011
Last verified: February 2011
  Purpose

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.


Condition
Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Insights on the Clinical Significance of the Uncinate Process Histopathology in Patients With Chronic Rhinosinusitis

Further study details as provided by Assuta Hospital Systems:

Biospecimen Retention:   Samples Without DNA

Pathologic uncinate process tissue


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sinus drainage
Adult patients with chronic rhinosinusitis who failed treatment with antibiotics and topical corticosteroids and underwent endoscopic sinus surgery. Preoperative evaluation included paranasal sinus CT scans. The diagnosis was confirmed by endoscopic examination showing purulent and/or mucopurulent discharge in the middle and/or superior meatus.

Detailed 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comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic rhinosinusitis whose uncinate process had to be removed to enable surgical access to the sinuses.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01296919

Locations
Israel
AssutaHS Recruiting
Tel Aviv, Israel
Contact: Eitan Yaniv, MD    052-2509890    docyaniv@yahoo.com   
Contact: Roee Landsberg, MD    052-4266359      
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Gilead Berger, MD AssutaHS, Meir Medical Center
Study Chair: Eitan Yaniv, MD Assuta Hospital Systems
Study Director: Roee Landsberg, MD Assuta Hospital Systems
  More Information

No publications provided

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01296919     History of Changes
Other Study ID Numbers: AssutaHS10-2010037
Study First Received: February 14, 2011
Last Updated: September 11, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Assuta Hospital Systems:
Chronic rhinosinusitis
Histopathology
Infundibulum
Lamina propria
Uncinate process

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014