A Study Comparing the outcomes of Double Layer Vs Single Layer Temporalis Fascia Graft in Type 1 Tympanoplasty for Subtotal and Anterior Perforations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the success rate of graft uptake between Double Layer versus Single Layer Temporalis Fascia Graft
研究概览
简要总结
The study “A study comparing the outcomes of Double Layer vs Single Layer Temporalis Fascia Graft in Type 1Tympanoplasty for Subtotal and Anterior Perforations “ will be conducted in department of Otorhinolaryngology,Varun Arjun Medical college and Rohilkhand Hospital,Banthra,Shahjahanpur,Uttar Pradesh 242307
A. The study will be conducted on subjects having tympanic membrane perforation attending the outpatient clinic in department of otorhinolaryngology , Varun Arjun Medical College and Rohilkhand Hospital ,Banthra ,Shahjahanpur,Uttar Pradesh based on inclusion and exclusion criteria
B. All patients selected for the study will undergo detailed history taking and written informed consent
C. Otorhinolaryngology assessment
D. Laboratory assessment
E. Patient will be admitted one day before the surgery
F. Patient will be allocated randomly into 2 groups:
Group A -Patient undergo Type 1 Tympanoplasty with Double Layer Temporalis Fascia Graft
Group B- Patient undergo Type 1 Tympanoplasty with Single Layer Temporalis Fascia Graft
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with inactive chronic otitis media (tubotympanic disease) ;Patient willing to participate in study,Patient with conductive Hearing Loss with AB Gap of less than 45dB;Subtotal/Anterior perforation in TM.
排除标准
- •Patient with recurrent chronic otitis media;Patient with central perforation with active discharge;Patient with Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension and Bronchial Asthma and Tuberculosis ,Patient with mixed hearing loss.
结局指标
主要结局
To compare the success rate of graft uptake between Double Layer versus Single Layer Temporalis Fascia Graft
时间窗: Once weekly for one month | Fortnightly for three months | Six months
次要结局
- To Compare the hearing outcome in Double Layer vs Single Layer Temporalis Graft(6th week)
研究者
Dr ASMIT BANSAL
Varun Arjun Medical College and Rohilkhand Hospital