CTRI/2019/05/019026招募中不适用
A randomized study of type I tympanoplasty with and without stabilization of graft by Anterior Tympanomeatal flap.
Dr Abhinav Srivastava1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年10月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- To see the outcome of surgery in terms of graft uptake and hearing gain in the two groups at 3 and 6 months
研究概览
简要总结
All the cases of inactive mucosal type of Chronic Suppurative Otitis Media(CSOM) will be divided into two groups based on lottery method of randomization. one group A will undergo type 1 tympanoplasty by conventional method and the other group B will be done by stabilization of graft by anterior tympanomeatal flap. The result will be evaluated in the two groups in terms of graft uptake and hearing gain at 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All patient of inactive mucosal disease, Patients 12 years and above, Patients with conductive hearing loss less than 50 dB.
排除标准
- •Patients less than 12 years, Patients with previous history of ear surgery,Patients with sensory neural hearing loss, Patients with congenital anomaly.
结局指标
主要结局
To see the outcome of surgery in terms of graft uptake and hearing gain in the two groups at 3 and 6 months
时间窗: 3 and 6 months
次要结局
- To see the blunting of anterior tympanomeatal angle and its affect on hearing(3 and 6 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
A study of repair of ear drum with and without full stability of graftCTRI/2019/05/019026Dr Abhinav Srivastava
尚未招募
不适用
A study to compare success using wet and dry graft in ear surgeryCTRI/2019/02/017654JLN MEDICAL COLLEGE100
终止
不适用
Balloon Dilation of the Eustachian TubeEustachian Tube DysfunctionNCT05270031Sunnybrook Health Sciences Centre15
尚未招募
不适用
A clinical trial to compare the outcomes of 2 types of tympanoplasty in terms of improvement in hearing and non discharging ear, the conventional tympanoplasty and total annular excision tympanoplastyCTRI/2022/04/041917AIIMS Bhubaneswar60
Unknown
3 期
A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis MediaChronic Otitis MediaTubotympanic DiseaseNCT00271778Karnataka Institute of Medical Sciences60