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NCT Number: NCT06618053

The Cost-effectiveness of Stapes Surgery for Otosclerosis Performed Under Local Versus General Anesthesia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon

Besançon, 25030, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cost-effectiveness and audiometry outcomes

Other

Evaluate cost-effectiveness of stapes surgery performed under local anesthesia as well as evaluate audiometry outcomes

Primary outcomes

  1. 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).

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: CESSO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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