Cholesteatoma, Middle Ear
Conditions
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.
Interventions
PROCEDURECholesteatoma surgery without exclusive endoscopic technique
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.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of revision surgery for residual or recurrent cholesteatoma | From index surgery up to 10 years of follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative air-bone gap (ABG) | Preoperative, at 4 months postoperatively, and at 1 year postoperatively. | 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. |
| Percentage of cholesteatoma procedures performed with each surgical approach per year | Each calendar year of the study period (2012-2023) | 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. |
| Number of participants managed with each surgical approach according to disease and patient characteristics | Post-EES period (September 2017 - December 2023) | Number of participants managed with each surgical approach (exclusively endoscopic vs microscopic/combined) within the post-EES period, reported according to STAM stage |
Countries
France
Outcome results
None listed