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Abstract
Introduction Cochlear implantation is an increasingly common procedure in the treatment of severe to profound sensorineural hearing loss (SNHL) in children and adults. It is often performed as a day-case procedure. The major drive towards day-case surgery has been from a logistical, economical and societal perspective, but we also speculate that the patient's quality of life (QoL) is at least equal to inpatient surgery if not increased as a result of rapid discharge and rehabilitation. Even though cochlear implantation seems well suited to a day-case approach and this even seems to be common practice in some countries, evidence is scarce and of low quality to guide us towards the preferred treatment option.
Methods and analysis A single-centre, non-blinded, randomised, controlled trial was designed to (primarily) investigate the effect on general QoL of day-case cochlear implantation compared to inpatient cochlear implantation and (secondarily) the effect of both methods on (subjective) hearing improvement, disease-specific QoL, tinnitus, vertigo and cost-effectiveness. 30 adult patients with severe to profound bilateral postlingual SNHL who are eligible for unilateral cochlear implantation will be randomly assigned to either the day-case or inpatient treatment group. The outcome measures will be assessed using auditory evaluations, questionnaires (preoperatively, at 1-week, 3-week, 3-month and 1-year follow-up) and costs diaries (weekly during the first month postoperatively, after which once in a month until 1-year follow-up). Preoperative and postoperative outcomes will be compared. The difference in costs and benefit will be represented using the incremental cost utility/effectiveness ratio. The analyses will be carried out on an intention-to-treat basis.
Ethics and dissemination This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL45590.041.13; V.5, November 2015). The trial results will be disseminated through peer-reviewed medical journals and presented at scientific conferences.
Trial registration number NTR4464; Pre-results.
- sensorineural hearing loss
- cochlear implantation
- day-case
- inpatient
- hearing results
- quality of life
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Footnotes
LSMD and IW contributed equally.
Contributors IW and LSMD: executive investigator, developing protocol, drafting manuscript, revising manuscript and approval of final version. ALS, VT, and HGXMT: surgeons, developing protocol, revising manuscript, approval of final version. WG: initial idea, principal investigator, developing protocol, revising manuscript, approval of final version.
Funding WG received an unrestrictive research grants from Cochlear, MED-EL GmbH and Advanced Bionics.
Competing interests None declared.
Ethics approval The study will be conducted according to the principles of the Declaration of Helsinki (Fortaleza, 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL45590.041.13; V.5, November 2015), and protocol modifications will be presented to the Institutional Review Board of the UMC Utrecht for approval.
Provenance and peer review Not commissioned; externally peer reviewed.