A Study to compare functional outcomes of Microscopic versus Endoscopic type 1 Tympanoplasty.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- We hope to get – Good success rate after endoscopic Tympanoplasty in terms of graft uptake and hearing improvement .
研究概览
简要总结
Tympanoplasty refers to any operation involving reconstruction of the tympanic membrane and/or the ossicular chain after eradication of disease.
The prevalence of Otitis media varies widely and causes a serious burden of illness globally. Chronic Suppurative Otitis Media (CSOM) accounts for a global burden of 65-330 million individuals with draining ears, 60% of whom suffer from significant hearing impairment.
Endoscopes make it possible to address the target pathology transcanal, while minimizing dissection of normal tissue done purely for exposure, leading to the evolution of minimally-invasive ear surgery and reducing morbidity.
As there are very few studies showing data of central india about endoscopic tympanoplasty, therefore we are doing this comparative study Between microscopic and endoscopic tympanoplasty.
We will be comparing their outcomes in terms of graft uptake and PTA at 3 months and 6 months interval post operatively.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of COM mucosal in age group 18-65 yrs, with Central perforations , consenting for surgery.
排除标准
- •Pregnant patients,smoker, known diabetic, any other comorbidities -COM squamosal. -Large Central perforation, subtotal or total perforations -Patient with Active ear discharge.
- •Patient with suspected ossicular discontinuity or fixation.
结局指标
主要结局
We hope to get – Good success rate after endoscopic Tympanoplasty in terms of graft uptake and hearing improvement .
时间窗: Follow up at 3 months and 6 months period after surgery
Less intraoperative and post operative pain.
时间窗: Follow up at 3 months and 6 months period after surgery
次要结局
未报告次要终点
研究者
Dr. Shivangi Patnecha
All India institute of medical sciences AIIMS, Raipur