跳至主要内容
临床试验/NCT06246682
NCT06246682招募中不适用

The Impact of Mastoid Condition and Ossicular Reconstruction on the Outcome of the Transcanal Endoscopic Management of Localized Atticoantral Cholesteatoma Patients

Sohag University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
2
主要终点
recurrence of cholesteatoma after procedure according to mastoid condition

研究概览

简要总结

The goal of this interventional study is to learn about the effect of mastoid process status and the method of ossicular reconstruction on the results of the procedure transcanal endoscopic management of patients with localized atticoantral cholesteatoma

详细描述

Acquired cholesteatoma is a special form of chronic otitis media in which keratinizing squamous epithelium grows from the tympanic membrane or/and the auditory canal skin into the middle ear mucosa. Acquired cholesteatomas of the middle ear are further divided into primary acquired and secondary acquired forms. The primary acquired cholesteatoma is the most frequent type of acquired cholesteatoma and develops by the progression of an initial retraction pocket into a cholesteatoma. Primary acquired cholesteatomas are named relative to the site of the pocket origin: (1) attic cholesteatoma consecutive to a pars flaccida pocket,(2) mesotympanic cholesteatoma due to a pars tensa pocket, and (3) combined forms, due to double pockets. The predominant form of acquired cholesteatoma in children develops in 80% from retraction pockets of the pars tensa whereas in adults, this form develops mainly in the pars flaccida.

The diagnosis of cholesteatoma is made on otoscopic examination, including endoscopic and microscopic evaluation, imaging, or surgical exploration. The symptoms of cholesteatoma vary; some cholesteatomas are asymptomatic, whereas others become infected and rapidly cause bone destruction. Some patients will present with slowly progressive conductive hearing loss and, frequently, with chronic otitis and purulent otorrhea. The otorrhea from an infected cholesteatoma often is malodorous because of the frequent infection with anaerobic bacteria. Some patients will have signs and symptoms of the complications of a cholesteatoma: vertigo and hearing loss caused by a labyrinthine fistula, facial nerve paralysis, or intracranial infection.

there are some contraindications to the use of exclusively endoscopic approaches. For example, if cholesteatoma involves the mastoid cavity, it is not possible to control and remove it by only a transcanal approach; the use of the microscope in combination with the endoscope is recommended. Also, a narrow external ear canal, or external ear malformation, can pose general anatomical difficulties for exclusively endoscopic approaches.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting with primary acquired localized atticoantral cholesteatoma.

排除标准

  • Age group: patients below 12 years old.
  • Patients presenting with congenital or secondary acquired cholesteatoma.
  • Patients presenting with extensive, residual, or recurrent cholesteatoma.
  • Patients with craniofacial anomalies.

结局指标

主要结局

recurrence of cholesteatoma after procedure according to mastoid condition

时间窗: six months postoperative after the procedure

measurement of changes in recurrence rate of cholesteatoma after its removal according to different types of mastoid process

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

Farghaly Abdelrahman Mekki

Assistant lecturer of otolaryngology sohag university

Sohag University

研究点 (2)

Loading locations...

相似试验