An observational study in Otitis Media With Effusion, sponsored by Pamukkale University. Completed. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Pamukkale University · Observational
The investigators asked the question if they can better estimate the middle ear status in OME that help them to decide between early intervention or longer follow up.
Purpose: Otitis media with effusion is an important problem in childhood. After proper diagnosis, generally 3 months of follow up has been recommended before surgical tympanostomy tube insertion. If the physician can estimate the status of the middle ear or fluid type better with a non-invasive method, we can suggest an early operation to these patients or decide to follow up more with no intervention. The purpose of the study is to compare the surgically confirmed middle ear effusions with wideband absorbance values and to differentiate them noninvasively before the operation.
Methods: A total of 123 children that were followed 3 months and treated surgically with the diagnosis of OME were included. Eighty-two sex, age-matched children were tested as control with wideband tympanometry. Ears were divided into four groups according to findings in the operation: serous, mucoid, adhesive, empty. Resonance frequency, 226 Hz, 1000 Hz compliance, Wideband Peak pressure, Absorbance measurements used for comparison.
85 studies on the registry are indexed under Otitis Media with Effusion; 15 are open to participants now.
This study's enrollment of 202 is above the median of 125 across 20 observational studies indexed under Otitis Media with Effusion.
Browse Otitis Media with Effusion studies →Pamukkale University is the lead sponsor of 340 studies on the registry; 62 are open to participants now.
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children with otitis media with effusion
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Exclusion Criteria:
Patients were divided into groups according to observation in surgery Empty ear in operation
Diagnostic Test: Wideband Tympanometry
Patients were divided into groups according to observation in surgery Serous fluid in operation
Diagnostic Test: Wideband Tympanometry
Patients were divided into groups according to observation in surgery Mucoid fluid in operation
Diagnostic Test: Wideband Tympanometry
Patients were divided into groups according to observation in surgery Adhesive tympanic membrane in operation
Diagnostic Test: Wideband Tympanometry
Control group. Subjects with no otitis media with effusion
Diagnostic Test: Wideband Tympanometry
Resonance frequency
Wideband resonance frequency was measured
Time frame: The same 1 day with the operation
Absorbance
Wideband absorbance of frequencies between 250-8000 Hz were measured
Time frame: The same 1 day with the operation
No study locations are listed for this record.
Plan to share: No — Data will be available in the university depository
No publications or documents are linked to this record.
Ran from Jan 2016 to primary completion in Dec 2018, 35 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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