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Clinical Trials/NCT04672187
NCT04672187
Completed
Not Applicable

Middle Ear Status in Cholesteatoma: the Associations of Preoperative Computed Tomography Scans, Audiologic Assessment, and Intraoperative Endoscopic Findings

Prince of Songkla University1 site in 1 country41 target enrollmentNovember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Middle Ear Cholesteatoma
Sponsor
Prince of Songkla University
Enrollment
41
Locations
1
Primary Endpoint
predictive factor of intraoperative endoscopic finding from preoperative ct finding and preoperative audiological assessment
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study is to assess the accuracy of preoperative HRCT of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

Detailed Description

The information of the preoperative HRCT scanning of the middle ear cavity in cholesteatoma combined with the preoperative audiologic assessment could be informed the intraoperative middle ear finding in the patients who were diagnosed with chronic otitis media with cholesteatoma, which influence the plan of surgical management. Whether these preoperative assessments can predict the intraoperative finding is unclear. The aim of this study is to assess the accuracy of preoperative HRCT of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
November 1, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yuvatiya Plodpai

Associate professor

Prince of Songkla University

Eligibility Criteria

Inclusion Criteria

  • The patients included in this study had otorrhea, hearing loss, or aural fullness that last more than 3 months. Otological examination revealed tympanic membrane perforation or retraction, along with cholesteatoma.

Exclusion Criteria

  • Patients who had a previous temporal bone fracture, concomitant with congenital craniofacial anomalies, or underwent previous otologic surgery were excluded.

Outcomes

Primary Outcomes

predictive factor of intraoperative endoscopic finding from preoperative ct finding and preoperative audiological assessment

Time Frame: 2 years

the association of preoperative ct finding and preoperative audiological assessment compared with intraoperative endoscopic middle ear finding in middle cholestaetoma

Secondary Outcomes

  • accuracy between preoperative ct finding and intraoperative endoscopic finding(2 years)

Study Sites (1)

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