Otosclerosis (in Dutch: otosclerose).
Conditions
Interventions
a day-case versus an inpatient approach to stapes surgery for otosclerosis. Day-case surgery involves same-day admittance and discharge, whereas inpatient surgery involves admission the day before sur
Sponsors
University Medical Centre Utrecht
Eligibility
Inclusion criteria
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; • Willingness and ability to participate in all scheduled procedures outlined in the research protocol; • General health allowing general anesthesia in an out-patient setting; • Quick access to communication and transportation in case of any complications; • Good understanding of the Dutch language.
Exclusion criteria
Exclusion criteria: • Previous middle ear surgery (other than previous stapes surgery); • Known aberrant (middle ear) anatomy in one or both ears; • Co-morbid middle or inner ear pathology, osteogenesis imperfecta, an active ear infection in one or both ears or active otosclerosis with Schwartze sign; • Disability that could interfere with audiologic evaluation and/or questionnaire fulfillment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative air conduction on pure-tone audiometry at 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Performance on pure-tone audiometry (mean air-bone gap, bone conduction thresholds, air conduction thresholds); - Performance on speech audiometry; - General and disease-specific quality of life - Tinnitus; - Vertigo; - Use of escape medication; - Intraoperative and postoperative complications; - Cost-utility analysis. | — |
Contacts
Public ContactInge Wegner
Department of Otorhinolaryngology University Medical Centre Utrecht
Outcome results
None listed