Day-case versus in-patient stapes surgery for otosclerosis: a randomized controlled trial.
- Conditions
- ossificationotosclerosis10027584
- Registration Number
- NL-OMON44763
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
Age >= 18;
Otosclerosis based on a clinical history of progressive hearing loss and pure-tone audiometry showing conductive hearing loss with an air-bone gap > 20 dB nHL in the range of 500, 1,000, 2,000 and 4,000 Hz;
Willingness and ability to participate in all scheduled procedures outlined in the research protocol;
General health allowing general anesthesia;
Quick access to communication and transportation in case of any complications;
Good understanding of the Dutch language.
Previous middle ear surgery other than stapes surgery;
Aberrant (middle ear) anatomy in one or both ears;
Co-morbid middle or inner ear pathology, osteogenesis imperfecta or an active ear infection in one or both ears;
Disability that could interfere with audiologic evaluation and/or questionnaire fulfillment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome measure is postoperative air conduction on pure-tone audiometry<br /><br>at 12 months follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are hearing improvement on pure-tone and speech<br /><br>audiometry, disease-specific and general quality of life, tinnitus, vertigo,<br /><br>cost-effectiveness and complications. </p><br>