Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial.
Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial.
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DOI：
10.1186/s13063-021-05878-2
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发表时间：
2021-12-09
期刊：
影响因子：
2.5
通讯作者：
Thomeer HGXM
中科院分区：
文献类型：
--
作者：
Jwair S;Boerboom RA;Versnel H;Stokroos RJ;Thomeer HGXM
为了保留接受人工耳蜗植入（CI）的感音神经性听力损失（SNHL）患者的残余听力，需要尽量减少对耳蜗微妙结构的插入创伤。手术方法包括传统的乳突切除术-后鼓室切开术（MPT）到达中耳，然后是耳蜗造口术（CO）或圆窗（RW）方法。这两种技术都有其优点和缺点。结构保存的另一个重要方面是电极阵列的设计。使用两种不同的设计：“直的”侧壁卧电极阵列（LW）或“预弯曲的”环抱蜗轴卧电极阵列（PM）。有趣的是，到目前为止，最好的手术方法和植入物的设计是不确定的。我们的假设是，四种可能的治疗方案之间的听力保护结果存在差异。我们设计了一项单中心、多组、随机对照试验来比较四组患者之间的插入创伤，每组患者都有电极阵列类型（LW或PM）和手术入路（RW或CO）的独特组合。总共有48名患者将被随机分配到这四个干预组之一。我们的主要目的是比较这四组之间的术后听力保护。其次，我们的目标是评估结构保护（即，标量易位，基底膜破裂或阵列尖端折叠）。第三，通过耳蜗电图（ECochG）比较听力和结构保留的客观结果。通过耳蜗造口或圆窗入路，使用不同的电极阵列类型进行耳蜗植入，是重度至极重度双侧感音神经性听力损失患者的标准医疗护理，因为它是一种相对简单且风险低的手术，可使患者受益匪浅。然而，残余听力的丧失仍然是一个问题。该试验是第一项随机对照试验，评估了几种CI治疗方案对耳蜗插入创伤听力保护的影响。荷兰试验注册中心（NTR）NL 8586。于2020年5月4日注册。登记后; 3/48例受试者在登记前入组。在线版本包含补充材料，可通过10.1186/s13063-021-05878-2获得。
In order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a “straight” lateral wall lying electrode array (LW) or a “pre-curved” perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that there is a difference in hearing preservation outcomes between the four possible treatment options. We designed a monocenter, multi-arm, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of an electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is the comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar translocation, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG). Cochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relatively simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation. Netherlands Trial Register (NTR) NL8586. Registered on 4 May 2020. Retrospectively registered; 3/48 participants were included before registration. The online version contains supplementary material available at 10.1186/s13063-021-05878-2.
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DOI：
10.1002/ar.22580
发表时间：
2012-11
期刊：
Anatomical record (Hoboken, N.J. : 2007)
影响因子：
--
作者：
Eshraghi AA;Nazarian R;Telischi FF;Rajguru SM;Truy E;Gupta C
通讯作者：
Gupta C
影响因子：
3.7
作者：
Fontenot, Tatyana Elizabeth;Giardina, Christopher Kenneth;Fitzpatrick, Douglas C.
通讯作者：
Fitzpatrick, Douglas C.
影响因子：
1.4
作者：
Mosnier, Isabelle;Celerier, Charlotte;Bernardeschi, Daniele
通讯作者：
Bernardeschi, Daniele
影响因子：
3.7
作者：
Gifford RH;Dorman MF;Skarzynski H;Lorens A;Polak M;Driscoll CL;Roland P;Buchman CA
通讯作者：
Buchman CA
影响因子：
1.6
作者：
Gfeller, Kate E;Olszewski, Carol;Oleson, Jacob
通讯作者：
Oleson, Jacob