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Day-case versus inpatient cochlear implantation: a randomized controlled trial.

Day-case versus inpatient cochlear implantation: a randomized controlled trial. - DAY-CI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44709
Enrollment
30
Registered
2013-12-11
Start date
2014-04-17
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deafness severe to profound bilateral sensorineural hearing loss

Interventions

Day-case versus inpatient surgery.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Primary outcome measure is general quality of life measured by the Health Utility Index - Mark 3.

Secondary

MeasureTime frame
Secondary outcome measures are disease-specific quality of life, complications and cost-effectiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)