Comparative Study Between Radical Mastoidectomy With and Without Mastoid Obliteration Operations in Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- best option for cholestatoma
研究概览
简要总结
Chronic otitis media (COM) has a significant impact on health issues since prehistoric time. It is a global disease, seen in all the continents of world having different environmental and socioeconomic background. COM is characterized as a permanent abnormality of the pars tensa or flaccida, most likely a result of earlier acute otitis media, negative middle ear pressure or otitis media with effusion. COM squamous active (cholesteatoma) is a type of COM, which is a mass formed by keratinizing squamous epithelium in the middle ear and/or mastoid, subepithelial connective tissue and by the progressive accumulation of keratin debris with/without surrounding inflammatory reaction.
详细描述
Paediatric cholesteatoma spread more extensively through the temporal bone than in adult as the temporal bone in children is well pneumatized. The disease in children is frequently more extensive and expanding, with more involvement of the peri-labyrinthine cells and petrous apex. It is a commonly encountered disease entity which requires prompt surgical management as early as possible. The management of cholesteatoma is solely surgical.
Comparatively the pediatric population has higher rates of recurrent and residual disease, possibly due to anatomic and physiologic differences. Eustachian tube anatomy and dysfunction predisposes children to more frequent infections and retraction pockets. Thus posing a greater challenge than in adults in treating cholesteatom.
The goals of surgery are to eliminate epithelial and bone disease thoroughly and prevent the recurrence, produce a dry and safe ear and to restore serviceable hearing
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient suffering from chronic suppurative otitis media, attico-antral (squamous) disease.
- •Age less than or equal to 18 years.
排除标准
- •Patient having an intracranial complication of chronic suppurative otitis media.
- •Bony erosion of sinus plate or dural plate or bone covering the Trautmann's triangle with granulations over the erosion in patients undergoing mastoid obliteration operation.
结局指标
主要结局
best option for cholestatoma
时间窗: about 3 years
what operation with least recurrence
次要结局
未报告次要终点
研究者
Michael Abdo
principal investigator
Assiut University