CTRI/2017/07/009165已完成不适用
Comparison of Endoscope assisted and Microscope assisted Ear Surgery in Chronic Otitis Media(Squamous Type)-A Randomised Clinical Trial
Jawaharlal Nehru Institiute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2016年1月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- 1.Disease clearance
研究概览
简要总结
The objectives of the study are to assess and compare the efficacy of endoscopic ear surgery with microscope assisted surgical techniques on disease clearance and to compare the postoperative hearing improvement after these techniques among the patients with chronic otitis media- squamous type.
The study hypothesis is ’Endoscope is better thanmicroscope assisted ear surgery in terms of disease clearance and hearingimprovement in patients diagnosed with chronicsuppurative otitis media (squamous type)’ .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients within the age limits who attend ENT OPD and diagnosed with Chronic Otitis Media(Squamous type) with no previous surgical intervention are recruited.
排除标准
- •1.Patients with Otitis externa 2.Patients with other comorbidities like Diabetes and Hypertension, 3.Patient with intracranial complications of CSOM, Patients with dead ear and patients with ear malformations.
结局指标
主要结局
1.Disease clearance
时间窗: 6 months after the each patient is operated.
2.Hearing improvement
时间窗: 6 months after the each patient is operated.
次要结局
- not applicable(not applicable)
研究者
研究点 (1)
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