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The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT01296919
Recruitment Status : Unknown
Verified February 2011 by Assuta Hospital Systems.
Recruitment status was:  Recruiting
First Posted : February 16, 2011
Last Update Posted : September 13, 2011
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease

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comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Insights on the Clinical Significance of the Uncinate Process Histopathology in Patients With Chronic Rhinosinusitis
Study Start Date : March 2010
Primary Completion Date : July 2010
Estimated Study Completion Date : December 2011
Groups and 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.

Outcome Measures

Biospecimen Retention:   Samples Without DNA
Pathologic uncinate process tissue

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296919

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
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

Responsible Party: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT01296919     History of Changes
Other Study ID Numbers: AssutaHS10-2010037
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: February 2011

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

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