Abstract
BackgroundOtosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss. It can be treated effectively by surgically removing (part of) the stapes and replacing it with a prosthesis. Increasingly, stapes surgery is performed as a day-case procedure. The major drive towards day-case surgery has been out of economic considerations. However, it is also increasingly an explicit patient request and leads to shorter waiting times for surgery, a reduced risk of infection and most likely positively influences the patient’s quality of life as a result of rapid discharge and rehabilitation. Even though stapes surgery seems well suited to a day-case approach, given the low complication rates and early recovery, evidence is scarce and of low quality.Methods and designA single-center unblinded randomized controlled trial was designed to (primarily) investigate the effect of hearing outcomes of day-case stapes surgery compared to inpatient stapes surgery and (secondarily) investigate the effect of both methods on quality of life, tinnitus, vertigo and cost-effectiveness. One hundred and twelve adult otosclerosis patients who are eligible for stapes surgery will be randomly assigned to either the day-case or inpatient treatment group. The primary and secondary outcome measures will be assessed using pure-tone audiometry (at approximately 2 months and 1 year follow-up), questionnaires (at 3 months and 1 year follow-up) and costs diaries (weekly the first month after which once a month until 1 year follow-up).Discussion/conclusionThis trial allows for a comparison between day-case and inpatient stapes surgery to investigate the hypothesis that day-case stapes surgery is associated with a higher quality of life and higher cost-effectiveness, while maintaining equal hearing results, compared to inpatient stapes surgery.Trial registrationNetherlands Trial Register (www.trialregister.nl): NTR4133, registration date 21st August 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s12901-016-0024-6) contains supplementary material, which is available to authorized users.
Highlights
Otosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss
Discussion/conclusion: This trial allows for a comparison between day-case and inpatient stapes surgery to investigate the hypothesis that day-case stapes surgery is associated with a higher quality of life and higher cost-effectiveness, while maintaining equal hearing results, compared to inpatient stapes surgery
Otosclerosis is characterized by abnormal sponge-like bone growth in the otic capsule, causing progressive hearing loss, vertigo and/or tinnitus [1]
Summary
This protocol is reported according to the SPIRIT Statement, an international guideline on reporting protocols [24]. The Utrecht Burden Questionnaire for tinnitus and vertigo will be administered directly postoperatively in case of direct postoperative tinnitus and/or vertigo: Patient satisfaction Patient satisfaction will be evaluated using the Utrecht patient satisfaction survey (Additional file 2; translated to English, original in Dutch) This seven-item questionnaire was developed in our center and contains questions regarding the hospital stay. This randomized controlled trial allows for a comparison between daycase and inpatient stapes surgery to investigate the hypothesis that day-case stapes surgery is associated with a higher QoL and higher cost-effectiveness, while maintaining equal hearing results, compared to inpatient stapes surgery This is the first high quality trial evaluating and quantifying the benefits of day-case stapes surgery for patients with otosclerosis. RAT, DMAK and WG are developing protocol, revising manuscript, approval of final version
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