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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00899561
First received: May 11, 2009
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition
Chronic Rhinosinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Middle Turbinate Histopathology and Computed Tomography Staging in Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • inflammation of soft tissue and bony elements of the middle turbinate [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis [ Time Frame: two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle turbinate samples of patients with limited, intermediate, and extensive chronic sinus disease.


Estimated Enrollment: 45
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  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 a limited (of 1-8), intermediate (9-16), and extensive (17-24) sinus disease.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899561

Contacts
Contact: Gilead Berger, MD berger45@netvision.net.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Principal Investigator: Gilead Berger, MD         
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Gilead Berger, MD       berger45@netvision.net.il   
Sponsors and Collaborators
Meir Medical Center
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Gilead Berger, MD Meir Medical Center
Principal Investigator: Roee Landsberg, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00899561     History of Changes
Other Study ID Numbers: MeirMc
Study First Received: May 11, 2009
Last Updated: March 16, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Chronic rhinosinusitis
Computed tomography
Histology
Middle turbinate
Morphometry
osteomyelitis
polyps

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

ClinicalTrials.gov processed this record on October 21, 2014