Derks Laura S M, Wegner Inge, Tange Rinze A, Kamalski Digna M A, Grolman Wilko
Department of Otorhinolaryngology - Head and Neck Surgery, University Medical Center Utrecht, PO BOX 85500, 3508 GA Utrecht, The Netherlands.
Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
BMC Ear Nose Throat Disord. 2016 Feb 27;16:3. doi: 10.1186/s12901-016-0024-6. eCollection 2016.
Otosclerosis 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.
A 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/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.
Netherlands Trial Register (www.trialregister.nl): NTR4133, registration date 21(st) August 2013.
耳硬化症的特征是耳囊内有骨质沉积，导致镫骨固定和进行性听力损失。通过手术切除（部分）镫骨并用假体置换可有效治疗。越来越多的镫骨手术作为日间手术进行。推动日间手术的主要动力是出于经济考虑。然而，这也越来越成为患者明确的要求，并且能缩短手术等待时间、降低感染风险，而且由于快速出院和康复，很可能对患者的生活质量产生积极影响。尽管镫骨手术似乎很适合日间手术方式，因为其并发症发生率低且恢复早，但相关证据稀缺且质量不高。
一项单中心非盲随机对照试验旨在（主要）研究日间镫骨手术与住院镫骨手术相比对听力结果的影响，（次要）研究两种方法对生活质量、耳鸣、眩晕和成本效益的影响。112名符合镫骨手术条件的成年耳硬化症患者将被随机分配到日间手术组或住院治疗组。主要和次要结局指标将通过纯音听力测定（分别在术后约2个月和1年随访时）、问卷调查（在术后3个月和1年随访时）以及成本日记（术后第一个月每周记录，之后每月记录一次直至1年随访）进行评估。
讨论/结论：本试验允许对日间镫骨手术和住院镫骨手术进行比较，以研究以下假设：与住院镫骨手术相比，日间镫骨手术在保持同等听力结果的同时，能带来更高的生活质量和更高的成本效益。
