Associations of Pre- and Intraoperative Endoscopic Findings of Middle Ear Status in Cholesteatoma

Completed

• Conditions: Middle Ear Cholesteatoma

• Registration Number: NCT04672187
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Last Update Submitted: 2020-12-11
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
predictive factor of intraoperative endoscopic finding from preoperative ct finding and preoperative audiological assessment	2 years	the association of preoperative ct finding and preoperative audiological assessment compared with intraoperative endoscopic middle ear finding in middle cholestaetoma

Secondary Outcome Measures

Name	Time	Method
accuracy between preoperative ct finding and intraoperative endoscopic finding	2 years	accuracy between preoperative ct finding and intraoperative endoscopic finding of middle ear cholesteatoma

Trial Locations

Locations (1)

Faculty of Medicine, Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand