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NCT06618053: CESSO
The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia
trial testing cost-effectiveness and audiometry outcomes in Otosclerosis in 40 participants. Completed in 15 July 2024.
15 July 2024
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Besancon |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 11 June 2024 |
| Primary completion | 15 July 2024 |
| Estimated completion | 15 July 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- cost-effectiveness and audiometry outcomes
Conditions studied
- Otosclerosis — all drugs for Otosclerosis →
Sponsor
Centre Hospitalier Universitaire de Besancon
Who can join
18 and older, any sex, with Otosclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06618053
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06618053 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Besancon
- Last refreshed: 1 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06618053.
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