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Completed

NCT Number: NCT04672187

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

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.

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Key information

Conditions

Middle Ear Cholesteatoma Cholesteatoma Cholesteatoma, Middle Ear Ear Diseases Keratosis Otorhinolaryngologic Diseases Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. accuracy between preoperative ct finding and intraoperative endoscopic finding

    Time frame: 2 years

    accuracy between preoperative ct finding and intraoperative endoscopic finding of middle ear cholesteatoma

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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