Comparison of Temporalis Fascia Graft versus Tragal Composite Graft in Type 1 Tympanoplasty: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
研究概览
简要总结
This study will be conducted in Tertiary Health Care centre in Manipur for a period of 2 years. The study will include patient with age 18 years and above attending in OPD of Otorhinolaryngology in RIMS, IMPHAL with diagnosis of Tympanic Membrane perforation and planned for Type 1 tympanoplasty full-filling the inclusion criteria. A total of 108 patients will be selected for the study. Block Randomization will be used and randomization sequence will be generated using www.sealedenvelope.com by entering the required data.codes will be assigned to each patient. The study will aim to compare post operative outcomes in Temporalis Fascia Graft vs Tragal Composite Graft in Type 1 Tympanoplasty in terms of Graft Uptake Rate and Hearing Outcome .
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
- •1.Age 18 years and above 2.Central perforation of tympanic membrane irrespective of cause of perforation
- •A dry ear for at least 6 weeks.
排除标准
- •1.patient with near total or total perforation 2.Revision Tympanoplasty 3.Patient with chronic otitis media squamousal type with cholesteatoma or retraction pockets 4.Sensorineural hearing loss.
研究者
Prof Dr Sudhiranjan Thingbaijam
Regional Institute Of Medical Sciences