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NCT Number: NCT07723547

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

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.

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Key information

Conditions

Cholesteatoma, Middle Ear Cholesteatoma Ear Diseases Keratosis Otorhinolaryngologic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU NICE

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cholesteatoma surgery without exclusive endoscopic technique

Procedure

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.

Primary outcomes

  1. Rate of revision surgery for residual or recurrent cholesteatoma

    Time frame: 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 outcomes

  1. Postoperative air-bone gap (ABG)

    Time frame: 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.

  2. Percentage of cholesteatoma procedures performed with each surgical approach per year

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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