Clinical Trial

Evolution of Surgery for Middle-ear Cholesteatoma After the Introduction of Exclusive Endoscopic Ear Surgery

Completed
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Summary
This retrospective observational study describes the evolution of surgical management of middle-ear cholesteatoma at Nice University Hospital over a 12-year period (January 2012 to December 2023), following the introduction of exclusive endoscopic ear surgery (EES) in September 2017. The study compares disease control (residual disease, recurrence, revision surgery) and audiometric outcomes (air-bone gap) between the pre-EES period (January 2012 to August 2017) and the post-EES period (September 2017 to December 2023), and between exclusive endoscopic, microscopic, and combined surgical approaches within the post-EES period. The aim is to characterize the patterns of surgical approach selection and to derive a practical guide for the appropriate use of EES in everyday cholesteatoma surgery.
Trial Details
NCT Number NCT07723547
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Cholesteatoma, Middle Ear
Enrollment 443 participants
Start Date 2012-01-01
Primary Completion 2026-01-09 (estimated)
Study Completion 2026-01-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-23