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临床试验/NCT07431125
NCT07431125
招募中
不适用

Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月1日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Improvement of the Airborne ( conductive ) gap

概览

简要总结

Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice. In the absence of middle ear effusion or tympanic membrane pathology, stapes fixation secondary to otosclerosis is often considered the most probable diagnosis. However, although otosclerosis is traditionally regarded as a bilateral disease, clinical presentation may be unilateral due to asymmetric disease progression or subclinical contralateral involvement. Other etiologies, including congenital ossicular anomalies, ossicular discontinuity, tympanosclerosis without tympanic membrane involvement, or oval window abnormalities, may mimic otosclerosis both clinically and audiologically. Consequently, exploratory tympanotomy remains the gold standard for definitive diagnosis, allowing direct assessment of ossicular chain mobility and confirmation of stapes fixation. Correlating preoperative clinical suspicion with intraoperative findings is therefore essential to better define the true causes of unilateral conductive hearing loss with an intact tympanic membrane.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • unilateral conductive hearing loss or mixed HL with intact Tympanic Membrane
  • Average Airborne Gap Above 20 decibels

排除标准

  • Sensorineural hearing loss
  • Chronic otitis media
  • TM perforation
  • Previous ear surgery

研究组 & 干预措施

Patients presented with unilatral conductive hearing loss with intact tympanic memebrane

Other

Patients who presented with unilateral conductive hearing loss with intact tympanic membrane will undergo exploration tympanoplasty to diagnose underlying causes and correct them surgically if possible

干预措施: Exporlation Tympanotomy (Procedure)

结局指标

主要结局

Improvement of the Airborne ( conductive ) gap

时间窗: up to three months Surgery

Difference between preoperative and postoperative Average Airbone gap in dicebel

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Nabil Selim

Resident doctor of otorhinolarngolgoy

Al-Azhar University

研究点 (1)

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