Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Otolaryngology, Shiraz University of Medical Sciences, Shiraz, Iran.
Clin Otolaryngol. 2019 May;44(3):299-304. doi: 10.1111/coa.13291. Epub 2019 Feb 28.
One research aspect of stapes surgery is various materials that are used to seal the oval window. Several materials are used to seal the oval window, for example adipose tissue, perichondrium, vein graft, gelatin sponge (Gelfoam), blood clot and soft connective tissue. Up to now, there has been no randomised clinical trial that has evaluated the effects of different types of sealing material on hearing outcomes after stapedotomy. Hence, the present study aimed to find out which of these materials; fat or Gelfoam was associated with better hearing outcome, when used as a sealing material.
This prospective, double-blind, randomised clinical trial was carried out on ears that had undergone stapedotomy.
Dastgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology centre in southern Iran.
A total of 176 primary stapedotomies were analysed. Fat harvested from the ear lobule was used in 86 ears and Gelfoam in 90 ears.
Preoperative and postoperative pure tone audiometric data and incidence of sensorineural hearing loss were evaluated.
Total of 90.7% of all ears in the fat group and 87.8% of ears in Gelfoam group achieved postoperative air-bone gap (ABG) within 20 dB, and this difference was not significant. There was no case of sensorineural hearing loss (defined as 10 dB or more reduction in BC threshold) in both groups in mean frequencies of 0.5-3 kHz. There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs 4 in the Gelfoam group. The occurrence of sensorineural hearing loss in different frequencies was not significant between the two groups (P > 0.05). In addition, there was no case of dead ear in either group.
We found similarity between hearing outcome in the Gelfoam and fat as sealing materials in stapedotomy. We believe that the first limitation of this study was the short-term follow-up in stapedotomy. The other issue is that one has to be cautious when using our result, which might not be applicable in larger fenestra stapedectomy.
镫骨手术的一个研究方面是各种用于封闭卵圆窗的材料。有几种材料被用于封闭卵圆窗，例如脂肪组织、软骨膜、静脉移植物、明胶海绵（Gelfoam）、血凝块和软结缔组织。到目前为止，还没有随机临床试验评估不同类型的密封材料对镫骨切开术后听力结果的影响。因此，本研究旨在确定在用作密封材料时，这些材料中的哪一种（脂肪或 Gelfoam）与更好的听力结果相关。
这是一项在接受镫骨切开术的耳朵上进行的前瞻性、双盲、随机临床试验。
伊朗南部转诊耳科中心 Shiraz 大学医学科学 Dastgheib 医院。
共分析了 176 例原发性镫骨切开术。86 耳使用取自耳甲腔的脂肪，90 耳使用 Gelfoam。
评估术前和术后纯音听力图数据和感音神经性听力损失的发生率。
脂肪组所有耳朵中有 90.7%，Gelfoam 组中有 87.8%的耳朵术后气骨导差（ABG）在 20dB 以内，差异无统计学意义。两组在 0.5-3kHz 的平均频率均无感音神经性听力损失（定义为 BC 阈值降低 10dB 或更多）病例。脂肪组有 9 例 4kHz 感音神经性听力损失，Gelfoam 组有 4 例。两组间不同频率感音神经性听力损失的发生率无统计学差异（P>0.05）。此外，两组均无死耳病例。
我们发现镫骨切开术中 Gelfoam 和脂肪作为密封材料的听力结果相似。我们认为这项研究的第一个局限性是镫骨切开术的短期随访。另一个问题是，在使用我们的结果时必须小心，因为这可能不适用于更大的窗孔镫骨切除术。
