OtosclerosisCESSONCT06618053
The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia
An observational study of Otosclerosis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Otosclerosis is a localized disorder of the otic capsule, characterized by bone resorption anterior to the oval window in the region of the fissula ante fenestram. This process leads to new sclerotic bone formation, resulting in stapes footplate fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis
- What is being tested?
- cost-effectiveness and audiometry outcomes
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2024to 15 Jul 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who underwent stapes surgery for otosclerosis from January 1, 2022, to December 31, 2023
Who may be able to join
- Patients diagnosed with otosclerosis and indicated for stapes surgery.
- Patients who underwent primary stapes surgery between January 1, 2022, and December 31, 2023.
- Surgery performed by utilizing the CO2 laser technique (Stapedotomy).
- Patients with complete medical records and audiometry data.
- Subjects do not object to the use of their personal data.
Who cannot join
- Patients with incomplete medical records (pre- or postoperative audiologic data were unavailable).
- Patients with other concurrent middle ear pathologies.
- Patients who underwent revision surgery for otosclerosis.
- performed by utilizing the microdrill technique or stapedectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Otosclerosis is a localized disorder of the otic capsule, characterized by bone resorption anterior to the oval window in the region of the fissula ante fenestram. This process leads to new sclerotic bone formation, resulting in stapes footplate fixation. It is one of the most common causes of progressive conductive hearing loss in young adults between the age of 30 and 50 year-old. As the disease advances, hearing loss can become mixed and even purely sensorineural due to the pathological process extending into the cochlea.
Stapes surgery is the gold standard procedure for restoring mechanical sound transmission through the middle ear. For patients who are not candidates for surgery, hearing aids offer a valid alternative. Over the years, stapes surgery has evolved into a minimally invasive procedure that can be safely performed as day surgery, under either local or general anesthesia.
Read more
The COVID-19 crisis has exacerbated a shortage in anesthesiology teams, limiting operating room availability. To address this issue, stapes surgery for otosclerosis under local anesthesia were increasingly performed. Local anesthesia has several advantages: it allows for immediate hearing tests after prosthesis placement, enabling early detection and correction of vertigo caused by prosthesis displacement, thus minimizing major complications. Additionally, local anesthesia reduces exposure to general anesthesia, thereby decreasing postoperative morbidities.
While there are few studies comparing outcomes and complications of stapes surgery based on the type of anesthesia, a systematic review in 2013 found no difference in postoperative air-bone gap (ABG), sensorineural hearing loss (SNHL), or postoperative vertigo between procedures performed under local versus general anesthesia. No studies have evaluated or compared the cost-effectiveness of stapes surgery for otosclerosis performed under local versus general anesthesia.
This study hypotheses that patients undergoing stapes surgery under local anesthesia will have equivalent outcomes to those under general anesthesia, with the potential for reduced costs and operative time.
- Conditions
- Otosclerosis
- Being tested
- cost-effectiveness and audiometry outcomes
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cost-effectiveness and audiometry outcomesOther
Evaluate cost-effectiveness of stapes surgery performed under local anesthesia as well as evaluate audiometry outcomes
| Study group | Role | What they receive |
|---|---|---|
| stapes surgery performed under local anesthesia | Not described Receives: Other: cost-effectiveness and audiometry outcomes | |
| stapes surgery performed under general anesthesia | Not described Receives: Other: cost-effectiveness and audiometry outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the cost-effectiveness of performing stapes surgery for otosclerosis under local anesthesia.
To compare the duration of hospital stay (in day) for patients undergoing the procedure under local anesthesia versus general anesthesia, and calculate the corresponding costs (in euros).
Measured: From the first day of hospitalisation (date of entry) for stapes surgery until the last day of hospitalisation (date of discharge) on average, up to 2 days
To analyse and describe the outcomes of stapes surgery for otosclerosis performed under both local and general anesthesia, and to compare these results with those reported in the literature.
The percentage of air-bone gap closure postoperatively in both the local anesthesia and general anesthesia groups undergoing the procedure under local anesthesia versus general anesthesia
Measured: From the first day of hospitalisation (date of entry) for stapes surgery until the last day of hospitalisation (date of discharge)on average, up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start11 Jun 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Tavernier, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618053
- Sponsor's protocol ID
- 2024/879
- Acronym
- CESSO
- Status last verified
- Sep 2024
- First submitted
- 10 Jun 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia
- ClinicalTrials.gov ID
- NCT06618053
- Acronym / sponsor ID
- CESSO / 2024/879
- Conditions
- Otosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 1 Oct 2024 (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.
Otosclerosis is a localized disorder of the otic capsule, characterized by bone resorption anterior to the oval window in the region of the fissula ante fenestram. This process leads to new sclerotic bone formation, resulting in stapes footplate fixation. It is one of the most common causes of progressive conductive hearing loss in young adults between the age of 30 and 50 year-old. As the disease advances, hearing loss can become mixed and even purely sensorineural due to the pathological process extending into the cochlea.
Stapes surgery is the gold standard procedure for restoring mechanical sound transmission through the middle ear. For patients who are not candidates for surgery, hearing aids offer a valid alternative. Over the years, stapes surgery has evolved into a minimally invasive procedure that can be safely performed as day surgery, under either local or general anesthesia.
The COVID-19 crisis has exacerbated a shortage in anesthesiology teams, limiting operating room availability. To address this issue, stapes surgery for otosclerosis under local anesthesia were increasingly performed. Local anesthesia has several advantages: it allows for immediate hearing tests after prosthesis placement, enabling early detection and correction of vertigo caused by prosthesis displacement, thus minimizing major complications. Additionally, local anesthesia reduces exposure to general anesthesia, thereby decreasing postoperative morbidities.
While there are few studies comparing outcomes and complications of stapes surgery based on the type of anesthesia, a systematic review in 2013 found no difference in postoperative air-bone gap (ABG), sensorineural hearing loss (SNHL), or postoperative vertigo between procedures performed under local versus general anesthesia. No studies have evaluated or compared the cost-effectiveness of stapes surgery for otosclerosis performed under local versus general anesthesia.
This study hypotheses that patients undergoing stapes surgery under local anesthesia will have equivalent outcomes to those under general anesthesia, with the potential for reduced costs and operative time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stapes surgery performed under local anesthesia | – | Other: cost-effectiveness and audiometry outcomes |
| stapes surgery performed under general anesthesia | – | Other: cost-effectiveness and audiometry outcomes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent stapes surgery for otosclerosis from January 1, 2022, to December 31, 2023
Key inclusion criteria (5 listed)
- Patients diagnosed with otosclerosis and indicated for stapes surgery.
- Patients who underwent primary stapes surgery between January 1, 2022, and December 31, 2023.
- Surgery performed by utilizing the CO2 laser technique (Stapedotomy).
- Patients with complete medical records and audiometry data.
- Subjects do not object to the use of their personal data.
Key exclusion criteria (4 listed)
- Patients with incomplete medical records (pre- or postoperative audiologic data were unavailable).
- Patients with other concurrent middle ear pathologies.
- Patients who underwent revision surgery for otosclerosis.
- performed by utilizing the microdrill technique or stapedectomy.
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 |
|---|---|---|
| cost-effectiveness and audiometry outcomesEvaluate cost-effectiveness of stapes surgery performed under local anesthesia as well as evaluate audiometry outcomes | Other | stapes surgery performed under general anesthesia, stapes surgery performed under local anesthesia |
Primary outcome
To demonstrate the cost-effectiveness of performing stapes surgery for otosclerosis under local anesthesia.
Time frame: From the first day of hospitalisation (date of entry) for stapes surgery until the last day of hospitalisation (date of discharge) on average, up to 2 days
To compare the duration of hospital stay (in day) for patients undergoing the procedure under local anesthesia versus general anesthesia, and calculate the corresponding costs (in euros).
To analyse and describe the outcomes of stapes surgery for otosclerosis performed under both local and general anesthesia, and to compare these results with those reported in the literature.
Time frame: From the first day of hospitalisation (date of entry) for stapes surgery until the last day of hospitalisation (date of discharge)on average, up to 2 days
The percentage of air-bone gap closure postoperatively in both the local anesthesia and general anesthesia groups undergoing the procedure under local anesthesia versus general anesthesia
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 1 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
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.
Laurent Tavernier principal investigator
CHU de Besançon
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 Otosclerosis, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 4 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 1 Oct 2024. 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?
To demonstrate the cost-effectiveness of performing stapes surgery for otosclerosis under local anesthesia. (time frame: From the first day of hospitalisation (date of entry) for stapes surgery until the last day of hospitalisation (date of discharge) on average, up to 2 days). The study lists 2 primary outcomes in all. 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 1 Oct 2024.