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Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis (CT)

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ClinicalTrials.gov Identifier: NCT00899561
Recruitment Status : Unknown
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : May 12, 2009
Last Update Posted : March 19, 2012
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date May 11, 2009
First Posted Date May 12, 2009
Last Update Posted Date March 19, 2012
Study Start Date December 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2009)
inflammation of soft tissue and bony elements of the middle turbinate [ Time Frame: two years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 11, 2009)
correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis [ Time Frame: two years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis
Official Title Correlation Between Middle Turbinate Histopathology and Computed Tomography Staging in Chronic Rhinosinusitis
Brief Summary

In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group.

The investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Middle turbinate samples of patients with limited, intermediate, and extensive chronic sinus disease.
Sampling Method Non-Probability Sample
Study Population patients with a limited (of 1-8), intermediate (9-16), and extensive (17-24) sinus disease.
Condition Chronic Rhinosinusitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 11, 2009)
45
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2012
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients with chronic rhinosinusitis who failed conservative medical treatment,
  • Patients who stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.

Exclusion Criteria:

  • Immunosuppressed patients,
  • Patients in whom no indication to excise the middle turbinate was found, AND
  • Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00899561
Other Study ID Numbers MeirMc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Gilead Berger, MD Meir Medical Center
Principal Investigator: Roee Landsberg, MD Tel-Aviv Sourasky Medical Center
PRS Account Meir Medical Center
Verification Date March 2012