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临床试验/NCT05813990
NCT05813990招募中不适用

Reconstructive Ear Surgery in Pediatric Population. Cross Sectional Study

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
reconstuctive ear surgery in pediartic population

研究概览

简要总结

The aim of the study is

  1. Evaluation of preoperative degree of hearing loss in pediatric population.
  2. Evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma.
  3. Assessment of best candidates for hearing restoration surgeries.
  4. Comparing different surgical techniques for hearing restoration in various ossicular disorders .
  5. Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population.

详细描述

Conductive hearing loss (CHL) results from impaired transmission of sound from the external auditory canal across the middle ear structures to the cochlea of the inner ear. A variety of disorders can affect the sound transmission pathway at the level of the ear canal, tympanic membrane, and ossicles prior to reaching the hearing organ.

Ossiculoplasty is the surgical restoration of the sound transmitting mechanism of the middle ear. Ossiculoplasty has been performed as early as the 1950s.A myriad of prosthetics and surgical techniques have been described over the last half-century, with no overall consensus on the ideal method of treatment.

Pediatric population are commonly known to develop conductive hearing loss secondary to various conditions such as chronic otitis media, otitis media with effusion, atelectatic otitis media and head trauma. Various methods have been fashioned to restore hearing in such patients however no consensus to the most optimum method for hearing restoration has been well established

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

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients aged ≤ 18years with CHL.
  • •patients who are candidate for ossiculoplasty as surgical treatment for them.

排除标准

  • •Patients with preoperative sensory neural hearing loss (SNHL).
  • •Patient with intra operative complications.
  • •Patients with intracranial and intratemporal complications.
  • •Patients with stapes foot plate fixation, broken graft and missed patients.
  • •Patients >18years.
  • •Patients who unfit for surgery.

研究组 & 干预措施

Pediatric patient with conductive hearing loss

Other

All pediatric patients aged below 18 years old will subjected to reconstructive ear surgery (ossiculoplasty)

干预措施: recostructive ear surgery (Other)

结局指标

主要结局

reconstuctive ear surgery in pediartic population

时间窗: 2m,6m and 1year

Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population using audiometry 2 months, 6month and 1 year after surgery to assess hearing results and prosthesis stability.

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

zeinab salah eldin mohamed

principal investigator

Assiut University

研究点 (1)

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