To investigate hearing improvement following day-case stapes surgery compared to in-patient stapes surgery and the effect of both methods on quality of life, cost-effectiveness and complication rates (mainly tinnitus and vertigo).
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is postoperative air conduction on pure-tone audiometry
at 12 months follow-up.
Secondary outcome
Secondary outcome measures are hearing improvement on pure-tone and speech
audiometry, disease-specific and general quality of life, tinnitus, vertigo,
cost-effectiveness and complications.
Background summary
Otosclerosis is characterized by bony deposits in the middle ear, resulting in
stapes fixation and progressive hearing loss. It can be treated effectively by
surgically removing (part of) the stapes and replacing it with a prosthesis.
Increasingly, stapes surgery is performed as a day-case procedure. The major
drive toward day-case surgery has been financial, but most likely positively
influences the patient*s quality of life as a result of rapid discharge and
rehabilitation. Even though stapes surgery seems well suited to a day-case
approach, given the low complication rates and early recovery, evidence is
scarce and of low quality.
Study objective
To investigate hearing improvement following day-case stapes surgery compared
to in-patient stapes surgery and the effect of both methods on quality of life,
cost-effectiveness and complication rates (mainly tinnitus and vertigo).
Study design
Un-blinded randomized controlled trial.
Intervention
Stapes surgery, either day-case or in-patient.
Study burden and risks
Complications known to arise following stapes surgery are tinnitus, vertigo,
sensorineural hearing loss or dead ear, alterations in taste and facial nerve
complaints. Compared to routine clinical practice, the study requires that half
of the participants undergo day-case surgery instead of in-patient surgery. A
risk of unforeseen (overnight) admittance following day-case surgery is
present. The benefits of day-case surgery are early discharge and early social
and emotional rehabilitation
Heidelberglaan 100
Utrecht 3508 AB
NL
Heidelberglaan 100
Utrecht 3508 AB
NL
Listed location countries
Age
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 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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45219.041.13 |
| OMON | NL-OMON29237 |