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

Centre Hospitalier Universitaire de Nice443 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

443

Conditions

Cholesteatoma, Middle Ear

Interventions

Cholesteatoma surgery without exclusive endoscopic techniquePROCEDURE

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Rate of revision surgery for residual or recurrent cholesteatoma

Proportion of patients requiring revision surgery during follow-up for residual or recurrent cholesteatoma. Residual cholesteatoma is defined as disease attributable to incomplete removal at the index surgery, identified by diffusion-weighted magnetic resonance imaging (DW-MRI) surveillance and confirmed intraoperatively at revision surgery. Recurrent cholesteatoma is defined as disease arising from a new tympanic membrane retraction pocket or perforation, diagnosed by otoscopic examination with DW-MRI support when clinically indicated

Time frame: From index surgery up to 10 years of follow-up

Secondary Outcomes

Postoperative air-bone gap (ABG)

Air-bone gap calculated as the mean threshold at 0.5, 1, and 2 kHz, measured before surgery and at 4 months and 1 year postoperatively. Reported as median \[interquartile range\] and compared between groups.

Time frame: Preoperative, at 4 months postoperatively, and at 1 year postoperatively.

Percentage of cholesteatoma procedures performed with each surgical approach per year

Percentage of middle-ear cholesteatoma procedures performed with each surgical approach (exclusively endoscopic, microscopic, or combined endoscopic-microscopic), reported for each calendar year of the study period.

Time frame: Each calendar year of the study period (2012-2023)

Number of participants managed with each surgical approach according to disease and patient characteristics

Number of participants managed with each surgical approach (exclusively endoscopic vs microscopic/combined) within the post-EES period, reported according to STAM stage

Time frame: Post-EES period (September 2017 - December 2023)