search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Day-case cochlear implantation compared to in-patient cochlear implantation in patients with severe to profound hearing loss.


- candidate number16835
- NTR NumberNTR4464
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mrt-2014
- Secondary IDsNL45590.041.13 
- Public TitleDay-case cochlear implantation compared to in-patient cochlear implantation in patients with severe to profound hearing loss.
- Scientific TitleDay-case versus inpatient cochlear implantation: a randomized controlled trial.
- ACRONYMDAY-CI
- hypothesisDay-case cochlear implantation is associated with higher quality of life and higher cost-effectiveness, while maintaining equal hearing results and adverse events, compared to in-patient cochlear implantation.
- Healt Condition(s) or Problem(s) studiedSensorineural Hearing Loss, Cochlear implant
- Inclusion criteria• Age ≥ 18; • Severe to profound 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 out-patient 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; • Previous cochlear implantation; • Aberrant (cochlear) anatomy on CT-scan or chronic ear infection; • Disability that could interfere with questionnaire fulfillment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2014
- planned closingdate1-okt-2016
- Target number of participants30
- InterventionsA day-case versus an inpatient approach for cochlear implantation. Day-case surgery involves same-day admittance and discharge, whereas inpatient surgery involves admission the day before surgery and discharge two days after surgery. Hearing outcomes, quality of life, complication rates and cost-effectiveness will be evaluated using audiological tests and questionnaires following both methods.
- Primary outcomeGeneral quality of life measured by the Health Utilities Index - Mark III at three weeks postoperatively.
- Secondary outcome• Complications; • Disease specific quality of life using the Glasgow Health Status Questionnaire and the Glasgow Benefit Inventory; • General quality of life using the EuroQol-5D; • Tinnitus using the Tinnitus Handicap Inventory, Tinnitus Questionnaire and Utrecht Tinnitus Burden Questionnaire for severity of tinnitus; • Vertigo using the Utrecht Vertigo Burden Questionnaire; • Cost-utility analysis using a costs diary.
- TimepointsFollow-up directly postoperatively, at three weeks postoperatively and at one year postoperatively. Furthermore a monthly costs diary will be fulfilled.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Inge Wegner
- CONTACT for SCIENTIFIC QUERIES Inge Wegner
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summarySUMMARY Rationale: cochlear implantation is an increasingly common procedure in the treatment of severe to profound sensorineural hearing loss in children and adults. Through electrical stimulation of the auditory nerve, an improvement in perception of sound and speech is achieved. 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. Objective: to investigate the cost-effectiveness of day-case cochlear implantation compared to inpatient cochlear implantation and the effect of both methods on hearing outcomes, quality of life and complication rates. Study design: un-blinded randomized controlled trial. Study population: adult patients with severe to profound post-lingual sensorineural hearing loss, aged 18 years and over, who are eligible for cochlear implantation. Intervention: day-case or inpatient surgery. Main study parameters/endpoints: primary outcome measure is general quality of life measured by the Health Utility Index – Mark III. Secondary outcome measures are hearing improvement, disease-specific quality of life, complications and cost-effectiveness. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: compared to routine clinical practice, the study requires half of the participants to undergo day-case surgery instead of inpatient surgery. A risk of unforeseen (overnight) admittance following day-case surgery is present. The possible benefits of day-case surgery are early discharge and early social and emotional rehabilitation.
- Main changes (audit trail)
- RECORD13-mrt-2014 - 11-apr-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl