The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis

NCT ID: NCT01296919

Last Updated: 2011-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).

Conditions

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Rhinosinusitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assuta Hospital Systems

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Berger, MD

Role: PRINCIPAL_INVESTIGATOR

AssutaHS, Meir Medical Center

Eitan Yaniv, MD

Role: STUDY_CHAIR

Assuta Hospital Systems

Roee Landsberg, MD

Role: STUDY_DIRECTOR

Assuta Hospital Systems

Locations

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AssutaHS

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Eitan Yaniv, MD

Role: primary

052-2509890

Roee Landsberg, MD

Role: backup

052-4266359

Other Identifiers

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AssutaHS10-2010037

Identifier Type: -

Identifier Source: org_study_id

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