NCT04959539已完成不适用
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- eradication of attic cholesteatoma
研究概览
简要总结
the main objective of the study is to compare endoscopic transcanal tympanoplasty with attico-antrostomy with endoscopic assisted canal wall up mastoidectomy in treatment of limited attic cholesteatoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cases of cholesteatoma limited to the middle ear and/or attic but not extending beyond the posterior end of the lateral semicircular canal (LSCC) proved radiologically with computed tomography (CT) scan
排除标准
- •Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach
结局指标
主要结局
eradication of attic cholesteatoma
时间窗: 6 months postoperative
number of participants with no recurrence documented by second look surgery or MRI diffusion
次要结局
未报告次要终点
研究者
Noha A.Elkholy
Principle investigator
Mansoura University
研究点 (2)
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