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

SUMMARY

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.

Day-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.

Follow-up directly postoperatively, at three weeks postoperatively and at one year postoperatively. Furthermore a monthly costs diary will be fulfilled.

A 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.