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

Evolution of Cholesteatoma Surgical Management After Adoption of Exclusive Endoscopic Ear Surgery: A Tertiary Center Experience

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 Overview

• Status: Completed
• Conditions: Cholesteatoma, Middle Ear
• Intervention / Treatment: Procedure: Cholesteatoma surgery without exclusive endoscopic technique

• Study Type: Observational
• Enrollment (Actual): 443

Contacts and Locations

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06000
      • CHU Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients operated for middle-ear cholesteatoma at the Department of Otolaryngology-Head and Neck Surgery, Nice University Hospital, a tertiary academic referral center. All procedures were performed by a single experienced otologic surgeon.

Description

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From index surgery up to 10 years of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Post-EES period (September 2017 - December 2023)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): January 9, 2026
• Study Completion (Actual): January 9, 2026

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Keratosis; Skin and Connective Tissue Diseases; Cholesteatoma; Cholesteatoma, Middle Ear
• Other Study ID Numbers: 26IUFC03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No