An observational study in Otosclerosis, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
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.
25 studies on the registry are indexed under Otosclerosis; 5 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 13 observational studies indexed under Otosclerosis.
Browse Otosclerosis studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 449 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who underwent stapes surgery for otosclerosis from January 1, 2022, to December 31, 2023
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Exclusion Criteria:
Other: cost-effectiveness and audiometry outcomes
Other: cost-effectiveness and audiometry outcomes
Evaluate cost-effectiveness of stapes surgery performed under local anesthesia as well as evaluate audiometry outcomes
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).
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 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
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
Plan to share: No
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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