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临床试验/NCT04131439
NCT04131439Unknown不适用

Role of Multislice Computed Tomography and Magnetic Resonance Imaging in Preoperative Cochlear Implant Evaluation

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Identifying contraindications for cochlear implant

研究概览

简要总结

This study investigates the role of the preoperative computed tomography (CT) and magnetic resonance imaging (MRI) before cochlear implants and their role in selecting suitable patients for surgery.

详细描述

Cochlear implant is the treatment of choice for deep sensorineural hearing loss, notably in those patients for whom conventional amplification devices do not provide significant clinical improvement. Imaging plays an important role in the workup of cochlear implant candidates not only to identify inner ear congenital and acquired abnormalities or cochlear nerve anomalies but also to detect temporal bone abnormalities that may be encountered during surgery and may alter surgical approach.

Some variations are potential surgical hazards that may lead to problems during the surgery and may alert the surgeon regarding potential surgical dangers and complications.

The radiologist and surgeon must be familiar with these imaging findings. Both computed tomography and magnetic resonance imaging should be used as they delineate, in different manners, cochlear and middle ear anatomy as well as other anatomical variants.

Mastoid pneumatization is important for planning the surgery. It is classified into pneumatic, diploic, sclerotic, and mixed. Effusion of the middle ear cleft should also be reported.

Korner's septum divides the mastoid process into a superficial squamous portion and a deep petrous portion. It may mislead the surgeon to the mastoid antrum during surgery. Mastoid emissary veins participate in extracranial venous drainage of the posterior fossa dural sinuses. Most of them disappear, however, some persist and enlarge.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients fulfilled criteria for cochlear implant including audiological criteria (as bilateral profound hearing loss not benefiting from hearing aid) and phoniatric criteria as IQ (using Stanford Binet intelligence scale) more than 80 with no medical, surgical, or radiological contraindication for surgery
  • Family motivation and commitment for audiologic and phoniatric rehabilitation and follow up
  • Confirmation of the presence of cochlear nerve using preimplant MRI.

排除标准

  • Patient who did not fulfill the criteria for indicating cochlear implant surgery
  • Patients with no records of preoperative investigations
  • Patients with major dysplasia or aplasia of the cochlea as a common cavity.

结局指标

主要结局

Identifying contraindications for cochlear implant

时间窗: Day 0

Identifying contraindications for cochlear implant including * cochlear nerve aplasia (evidenced by MRI) * cochlear and/or labyrinthine aplasia * absence of the internal auditory canal and of the petrous apex bone * absence or fusion of the ossicles

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

Mohamed Abdel-Tawab Mohamed

Principal investigator

Assiut University

研究点 (1)

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