The Comparison of Tympnoplasty with Temporalis Fascia Graft Versus Cartilage Composite Graft 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
- 60
- 试验地点
- 1
- 主要终点
- Post operative outcomes assesed
研究概览
简要总结
To do a Prospective study in the department of ENT , SRM Medical College Hospital AndResearch Centre , Kattankulathur to evalute the effectiveness of usage ofcartilage composite graft in patients undergoing tympanoplasty from aug 2018 tojan 2020 with follow up upto 3 months.Patients will be randomised into 2 groups: case group with 30 patients who will receive Partilage composite graft andcontrol group who will include 30 patients who will receive temporalus fasciagraft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.patients with anterior perforation,eustitian tube dysfunction,recurrent perforation 2.patients who are primary tympanoplasty cases with subtotal or large perforation.
- •3.patients diagnosed with CSOM Mucosal Type 4.patients with atleast 3 weeks dry period.
排除标准
- •1.patients with active infection.
- •2.Unsafe type of CSOM 3.patients having discharge ear.
结局指标
主要结局
Post operative outcomes assesed
时间窗: Post operative assesments on | 1.8 th day | 2.15 th day | 3.30 th day | 4.45 th day | 5.60 th day | 6.75 th day | 7.90 th day
2)Graft Displacement
时间窗: Post operative assesments on | 1.8 th day | 2.15 th day | 3.30 th day | 4.45 th day | 5.60 th day | 6.75 th day | 7.90 th day
4)Webbers Test
时间窗: Post operative assesments on | 1.8 th day | 2.15 th day | 3.30 th day | 4.45 th day | 5.60 th day | 6.75 th day | 7.90 th day
1)Epithelialisation Of Graft
时间窗: Post operative assesments on | 1.8 th day | 2.15 th day | 3.30 th day | 4.45 th day | 5.60 th day | 6.75 th day | 7.90 th day
3)Rinnes Test
时间窗: Post operative assesments on | 1.8 th day | 2.15 th day | 3.30 th day | 4.45 th day | 5.60 th day | 6.75 th day | 7.90 th day
5)Perforation Closure
时间窗: Post operative assesments on | 1.8 th day | 2.15 th day | 3.30 th day | 4.45 th day | 5.60 th day | 6.75 th day | 7.90 th day
6)Overall Outcome
时间窗: Post operative assesments on | 1.8 th day | 2.15 th day | 3.30 th day | 4.45 th day | 5.60 th day | 6.75 th day | 7.90 th day
次要结局
- Hearing improvement which is assessed by Pure Tone Audiometry(60 th Post Operative Day)