Cholesteatoma, Middle EarNCT07723547
Evolution of Surgery for Middle-ear Cholesteatoma After the Introduction of Exclusive Endoscopic Ear Surgery
An observational study of Cholesteatoma, Middle Ear, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cholesteatoma, Middle Ear
- What is being tested?
- Cholesteatoma surgery without exclusive endoscopic technique
- Type of treatment
- Surgery or procedure
- How many people
- 443 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 9 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Absence of cholesteatoma at intraoperative examination
- Cholesteatoma originating outside the middle ear (e.g., external auditory canal cholesteatoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cholesteatoma, Middle Ear
- Being tested
- Cholesteatoma surgery without exclusive endoscopic technique
- Medical subject headings
- Cholesteatoma, Middle Ear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholesteatoma surgery without exclusive endoscopic techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Cholesteatoma surgery without exclusive endoscopic technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From index surgery up to 10 years of follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: Post-EES period (September 2017 - December 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jan 2012
- Primary completion9 Jan 2026
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesteatoma, Middle EarStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723547
- Sponsor's protocol ID
- 26IUFC03
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Cholesteatoma Surgical Management After Adoption of Exclusive Endoscopic Ear Surgery: A Tertiary Center Experience
- ClinicalTrials.gov ID
- NCT07723547
- Acronym / sponsor ID
- 26IUFC03
- Conditions
- Cholesteatoma, Middle Ear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-EES period (January 2012 - August 2017) | – | Procedure: Cholesteatoma surgery without exclusive endoscopic techniqueCholesteatoma 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) | – | Procedure: Cholesteatoma surgery without exclusive endoscopic techniqueCholesteatoma 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Absence of cholesteatoma at intraoperative examination
- Cholesteatoma originating outside the middle ear (e.g., external auditory canal cholesteatoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholesteatoma surgery without exclusive endoscopic techniqueCholesteatoma 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 or surgery | Post-EES period (September 2017 - December 2023), Pre-EES period (January 2012 - August 2017) |
Primary outcome
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
3 secondary outcomes
Postoperative air-bone gap (ABG)
Time frame: Preoperative, at 4 months postoperatively, and at 1 year postoperatively.
Percentage of cholesteatoma procedures performed with each surgical approach per year
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
Time frame: Post-EES period (September 2017 - December 2023)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholesteatoma, Middle Ear, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of revision surgery for residual or recurrent cholesteatoma (time frame: From index surgery up to 10 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.