Clinical trial NCT06618053: The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia
Official title: The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otosclerosis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent stapes surgery for otosclerosis from January 1, 2022, to December 31, 2023

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To demonstrate the cost-effectiveness of performing stapes surgery for otosclerosis under local anesthesia.
timeFrame: 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
measure: 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.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Laurent Tavernier
role: PRINCIPAL_INVESTIGATOR
References: