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Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03975842
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Condition or disease Intervention/treatment
Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Other: Sinonasal and otologic evaluation

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps
Actual Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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)

Primary Outcome Measures :
  1. The prevalence of OME in CRSwNP patients. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)

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

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT03975842     History of Changes
Other Study ID Numbers: 30138520
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
otitis media with effusion (OME)
risk factor
endoscopic nasal examination
otoscopic examination
pure-tone audiometry

Additional relevant MeSH terms:
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Nasal Polyps
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathological Conditions, Anatomical