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

Middle Ear Cholesteatoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672187
• Other study ID #: EC-60-237-131
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2020
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholesteatoma
• Cholesteatoma, Middle Ear
• Middle Ear Cholesteatoma

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive factor of intraoperative endoscopic finding from preoperative ct finding and preoperative audiological assessment	the association of preoperative ct finding and preoperative audiological assessment compared with intraoperative endoscopic middle ear finding in middle cholestaetoma	2 years
Secondary	accuracy between preoperative ct finding and intraoperative endoscopic finding	accuracy between preoperative ct finding and intraoperative endoscopic finding of middle ear cholesteatoma	2 years