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NCT03975842 Clinical Trial

Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps

Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Clinical Trial

Official title:
Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03975842
Other study ID # 30138520
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date December 2012

Study information
Verified date June 2019
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The relationship between otitis media with effusion (OME) and chronic rhinosinusitis with nasal polyposis (CRSwNP) remains unclear. A cross-sectional study of 80 consecutively presenting patients who were diagnosed with CRSwNP was conducted. The aim was to ascertain the prevalence of OME in CRSwNP patients, to determine whether the severity of CRSwNP affected OME, and to identify risk factors for OME in CRSwNP patients.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Patients over 15 years of age

- Presence of chronic rhinosinusitis with nasal polyposis (CRSwNP) previously diagnosed or diagnosed at study's onset by endoscopic nasal examination

Exclusion Criteria:

- Presence of a mucopurulent discharge or granuloma during endoscopic nasal examination

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sinonasal and otologic evaluation
At onset, each participant had: sinonasal evaluation (several nasal signs and symptoms were evaluated, bilateral endoscopic nasal examination, computed tomography (CT) of the sinuses when sinus surgery became necessary). otologic evaluation (evaluation of middle ear status, documentations of personal history of otologic disease, otoscopic examination, pure-tone audiometry and tympanometry)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome
Type Measure Description Time frame Safety issue
Primary The prevalence of OME in CRSwNP patients. 2 years