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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06403319
Other study ID # OME-S-24-00723
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2009
Est. completion date December 31, 2020

Study information

Verified date May 2024
Source Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Otitis media with effusion (OME) is thought to be associated with comorbidities such as allergic rhinitis, gastroesophageal reflux disease, asthma, and more. Many of these comorbidities can be caused by type 2 inflammation (T2I). This study aims to characterize the risk of undergoing OME surgery. This retrospective, matched-cohort study involved the retrospective recruitment of patients from 2009 to 2020, using the Taiwan National Health Insurance Research Database (NHIRD)


Recruitment information / eligibility

Status Completed
Enrollment 100622
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosis of OME - At least two outpatient visits or one hospitalization record - Medical records within the database Exclusion Criteria: - Participants younger than 4 years old - Participants with unclear demographic information - Participants with a history of ear surgery or congenital ear anomalies - Participants who had undergone OME surgery before the index date

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary The number of participants with OME who requiring surgical intervention surgical intervention including procedures such as myringotomy and adenoidectomy 10 years
See also
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