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比较桶柄式和软骨鼓膜成形术技术用于修复鼓膜全层或前侧穿孔的随机临床试验

Randomized Clinical Trial Comparing Bucket Handle and Cartilage Tympanoplasty Techniques for the Reconstruction of Subtotal or Anterior Tympanic Membrane Perforation.

作者信息

Asghari Alimohamad, Mohseni Mohammad, Daneshi Ahmad, Nasoori Yasser, Rostami Sara, Balali Maryam

机构信息

Skull Base Research Center, Iran University of Medical Sciences, Tehran, Iran.

ENT and Head & Neck Research Center and Department, Hazrat Rasoul Akram Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.

出版信息

Int J Otolaryngol. 2018 May 22;2018:2431023. doi: 10.1155/2018/2431023. eCollection 2018.

Abstract

OBJECTIVE

The purpose of the study is to compare the clinical outcome of the two techniques of Bucket Handle Tympanoplasty and Cartilage Tympanoplasty in achieving success in graft survival as well as acceptable auditory results. 60 patients who suffered chronic otitis media with anterior perforation of the tympanic membrane were chosen. The patients were randomly assigned using Block Randomization Method of two groups including patients who underwent Bucket Handle Tympanoplasty ( = 30) or those that underwent Cartilage Tympanoplasty ( = 30). The patients were followed up for 1, 3, 6, and 12 months postoperatively.

RESULTS

The mean PTA was lower in Bucket Handle Tympanoplasty group as case group compared to Cartilage Tympanoplasty group as the control ( = 0.023). No significant statistical differences had identified passing through the time, in terms of PTA outcome ( Value = 0.547) and SRT outcome ( Value = 0.352), between Bucket Handle Tympanoplasty group and the Cartilage Tympanoplasty group. In total, postoperative tympanic membrane perforation was found in 10.0% of patients in Cartilage Tympanoplasty group and 13.3% in Bucket Handle Tympanoplasty group with no difference ( = 0.500).

CONCLUSIONS

Hearing improvements in both methods were similar.

REGISTRATION NUMBER

The trial is registered with IRCT2016022626773N1.

摘要

目的

本研究旨在比较桶柄状鼓室成形术和软骨鼓室成形术这两种技术在移植物存活成功以及获得可接受听觉结果方面的临床疗效。选取了60例患有慢性中耳炎且鼓膜前部穿孔的患者。采用区组随机化方法将患者随机分为两组,一组为接受桶柄状鼓室成形术的患者(n = 30),另一组为接受软骨鼓室成形术的患者(n = 30)。对患者术后1、3、6和12个月进行随访。

结果

作为病例组的桶柄状鼓室成形术组的平均纯音听阈(PTA)低于作为对照组的软骨鼓室成形术组(P = 0.023)。在PTA结果(P值 = 0.547)和短增量敏感指数(SRT)结果(P值 = 0.352)方面,桶柄状鼓室成形术组和软骨鼓室成形术组在随访时间上未发现显著统计学差异。总体而言,软骨鼓室成形术组10.0%的患者和桶柄状鼓室成形术组13.3%的患者术后出现鼓膜穿孔,差异无统计学意义(P = 0.500)。

结论

两种方法的听力改善情况相似。

注册号

该试验已在IRCT2016022626773N1注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b087/5987340/e8bac59e18ca/IJOTO2018-2431023.001.jpg

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