Day-case stapes surgery compared to in-patient surgery in patients with otosclerosis.
- Conditions
- Otosclerosis (in Dutch: otosclerose).
- Registration Number
- NL-OMON29237
- Lead Sponsor
- niversity Medical Centre Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 112
Inclusion Criteria
• 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 and a perceptive hearing loss < 35 dB nHL in the range of 500, 1000, 2000 and 4000 Hz;
Exclusion Criteria
• Previous middle ear surgery (other than previous stapes surgery);
• Known aberrant (middle ear) anatomy in one or both ears;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative air conduction on pure-tone audiometry at 12 months follow-up.
- Secondary Outcome Measures
Name Time Method - Performance on pure-tone audiometry (mean air-bone gap, bone conduction thresholds, air conduction thresholds);<br>- Performance on speech audiometry;<br>- General and disease-specific quality of life<br>- Tinnitus;<br>- Vertigo;<br>- Use of escape medication;<br>- Intraoperative and postoperative complications;<br>- Cost-utility analysis.