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

NCT00899561 | Unknown DMC

• 1 other identifier: MeirMc
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Rhinosinusitis

Keywords

Chronic rhinosinusitis; Computed tomography; Histology; Middle turbinate; Morphometry; osteomyelitis; polyps

Outcome Measures

Primary Outcomes (1)

• inflammation of soft tissue and bony elements of the middle turbinate

  two years

Secondary Outcomes (1)

• correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis

  two years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with a limited (of 1-8), intermediate (9-16), and extensive (17-24) sinus disease.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Meir Medical Center: lead
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (2)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Osteomyelitis; Polyps

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilead Berger, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

• Roee Landsberg, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilead Berger, MD

CONTACT

berger45@netvision.net.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 12, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

IL (2)