The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis
Recruitment status was Recruiting
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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 |
|---|
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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 |
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 |
|---|
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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.
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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comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).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 |
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| Israel | |
| AssutaHS | Recruiting |
| Tel Aviv, Israel | |
| Contact: Eitan Yaniv, MD 052-2509890 docyaniv@yahoo.com | |
| Contact: Roee Landsberg, MD 052-4266359 | |
| 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:
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Sinusitis Paranasal Sinus Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013