Evolution of Surgery for Middle-ear Cholesteatoma After the Introduction of Exclusive Endoscopic Ear Surgery | NCT07723547

NCT07723547

Overview

NCT ID: NCT07723547
Lead Sponsor: Centre Hospitalier Universitaire de NiceOTHER
Official Title: Evolution of Cholesteatoma Surgical Management After Adoption of Exclusive Endoscopic Ear Surgery: A Tertiary Center Experience
Brief 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.
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Jul 23, 2026Actual
Start Date: Jan 1, 2012Actual
Primary Completion Date: Jan 9, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patient operated for middle-ear cholesteatoma at the Department of Otolaryngology-Head and Neck Surgery, Nice University Hospital

Surgery performed between January 1, 2012 and December 31, 2023

Intraoperative confirmation of cholesteatoma

Exclusion Criteria:

Absence of cholesteatoma at intraoperative examination

Cholesteatoma originating outside the middle ear (e.g., external auditory canal cholesteatoma)

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 443Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: CHU NICE

Similar Studies

Participant Group/Arms

Pre-EES period (January 2012 - August 2017)

Cholesteatoma surgery performed under the operating microscope or via a combined endoscopic-microscopic approach. Exclusive endoscopic ear surgery (EES) was not used during this period. Procedures included tympanoplasty, canaloplasty, mastoidectomy (canal wall up or canal wall down), and ossiculoplasty as required by disease extension.

Procedure: Cholesteatoma surgery without exclusive endoscopic technique

Post-EES period (September 2017 - December 2023)

Cholesteatoma surgery performed using one of three approaches: exclusive endoscopic ear surgery (EES, totally transcanal endoscopic), microscopic surgery, or combined endoscopic-microscopic surgery. The choice of approach was made by the operating surgeon on a case-by-case basis based on preoperative high-resolution CT findings, examination of the external auditory canal, and the patient's surgical history. Procedures included tympanoplasty, canaloplasty, mastoidectomy, and ossiculoplasty as required.

Procedure: Cholesteatoma surgery without exclusive endoscopic technique