Endoscopic ear surgery versus Conventional microscopic ear surgery in patients with limited squamosal chronic otitis media, A Randomized Controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Comparison of mean/median MESVI score will be considered as the primary outcome. A difference of at least 2 in
研究概览
简要总结
This RCT aims to compare endoscopic ear surgery with conventional microscopic ear surgery in patients with limited squamosal disease. The study will include 64 patients meeting inclusion criteria over 1.5 years, conducted at AIIMS Gorakhpur. The study evaluates both techniques in terms of intraoperative exposure using MESVI Score, post-operative pain, hearing improvement and healing. Findings are expected to provide evidence on weather endoscopic surgery offers advantage over microscopic for limited disease management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All consenting adult patients (18-60 years) Limited squamosal disease (not involving the antrum) Disease extent confirmed by HRCT temporal bone Both approaches of surgery performed by single surgeon proficient in both microscopic and endoscopic technique.
排除标准
- •Patients with extensive disease that is involving the antrum Patients with any otogenic complications Revision surgery.
结局指标
主要结局
Comparison of mean/median MESVI score will be considered as the primary outcome. A difference of at least 2 in
时间窗: Intraoperative after completion of drilling
total scores between two study groups would be considered clinically significant.
时间窗: Intraoperative after completion of drilling
次要结局
- Mean/median VAS pain score at 24 hr postoperative period among study groups.
- Mean/median intraoperative duration among study group.
- Mean/median PTA-AB dB gap at 2 wk, 4 wk and 6 wk among study groups.
研究者
Nishtha Duggal
Department of ENT AIIMS Gorakhpur