Comparison of Outcome of Myringotomy With or Without Ventilation Tube in Children With Glue Ears
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement in hearing
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of myringotomy with ventilation tube insertion to myringotomy alone in improving hearing in children with glue ear.
The main question it aims to answer is:
Does adding a ventilation tube to myringotomy lead to greater improvement in hearing compared to myringotomy alone? Researchers will compare these two surgical techniques to determine which offers better outcomes for children with otitis media with effusion.
The Participants will:
- Have their hearing evaluated before surgery
- Undergo either myringotomy with ventilation tube insertion or myringotomy alone
- Have their hearing evaluated at follow-up visits at 2 weeks, 1 month, and 3 months post-operatively
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
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cases of otitis media with effusion
- •more than 20 decibel (dB) conductive hearing loss on pure tone audiometry
- •non-responder to medical treatment after three months of medical treatment
排除标准
- •Children having recurrent otitis media
- •Discharging ears
- •History of bleeding disorder
结局指标
主要结局
Improvement in hearing
时间窗: Before and Three months post operatively
The degree of hearing loss (dB) on pure tone audiometry was done before and after surgical procedure. Improvement in hearing level was labelled if there was decrease in hearing loss of 25% from baseline.
次要结局
- Hearing Loss (dB)(Before and Three months post operatively)
- Degree of Hearing Loss(Before and Three months post operatively)
研究者
Dr. Mudasir Abbas
Principal Investigator
Allama Iqbal Teaching Hospital