A prospective audit of tympanoplasty and evaluation of factors affecting the outcome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 1. To assess the rate of perforation closure and remission of ear discharge after tympanoplasty at 3 months
研究概览
简要总结
Given the heterogeneity in literature regarding the factors influencing outcome in tympanoplasty result, we intend to analyze our results of tympanoplasty, prospectively in adult patients. Through this study, we would identify and categorize comprehensively all possible factors and determine the degree of influence they have on outcomes.
This can help in improved counselling of the patients preoperatively regarding the prognosis of surgical repair of tympanic membrane defects.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with mucosal chronic otitis media undergoing type-1 tympanoplasty.
排除标准
- •Patients operated by surgeons with less than 18 months experience
- •patients with Sensorineural hearing loss
- •complicated CSOM
- •traumatic perforation
- •revision surgery.
结局指标
主要结局
1. To assess the rate of perforation closure and remission of ear discharge after tympanoplasty at 3 months
时间窗: At 3 months
2. to assess the hearing change post surgery at 3 months
时间窗: At 3 months
3. to assesss the factors affecting the above mentioned objectives
时间窗: At 3 months
次要结局
- 1. To assess the rate of perforation closure and remission of ear discharge after type 1 tympanoplasty at 6 and 12 months(2. to assess the hearing change post surgery at 6 and 12 months)
研究者
Dr. Ashish Kumar Arya
All India Institute of Medical Sciences, New Delhi