To investigate the cost-effectiveness of day-case cochlear implantation compared to inpatient cochlear implantation and the effect of both methods on quality of life.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is general quality of life measured by the Health
Utility Index - Mark 3.
Secondary outcome
Secondary outcome measures are disease-specific quality of life, complications
and cost-effectiveness.
Background summary
Cochlear implantation is an increasingly common procedure in the treatment of
severe to profound sensorineural hearing loss in children and adults. In other
Western countries, cochlear implantation is increasingly 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 cochlear implantation 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 the cost-effectiveness of day-case cochlear implantation
compared to inpatient cochlear implantation and the effect of both methods on
quality of life.
Study design
Un-blinded randomized controlled trial.
Intervention
Day-case versus inpatient surgery.
Study burden and risks
Compared to routine clinical practice, the study requires that half of the
participants undergo day-case surgery instead of inpatient 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 years;
Severe to profound bilateral post-lingual sensorineural hearing loss defined as >= 70 dB nHL on pure-tone audiometry in the range of 500, 1000 and 2000 Hz;
Willingness and ability to participate in all scheduled procedures outlined in the research protocol;
General health allowing general anesthesia in an outpatient setting;
Quick access to communication and transportation in case of any complications;
Good understanding of the Dutch language.
Exclusion criteria
Severe to profound pre-lingual sensorineural hearing loss;
Severe to profound unilateral sensorineural hearing loss;
Previous cochlear implantation;
Aberrant (cochlear) anatomy on CT-scan or chronic ear infection;
General health does not allow general anesthesia in an outpatient setting;
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 | NL45590.041.13 |
| OMON | NL-OMON26971 |