A randomized control study to compare the outcomes of total annular excision tympanoplasty and conventional tympanoplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Graft uptake will be measured by otoscopy
研究概览
简要总结
One of the complication associated with theconventional technique of tympanoplasty is a continuously discharging tympanic membrane- an entity named red drumconundrum. Mucosalisation of the graft Post tympanoplasty, may lead tocontinuous or intermittent discharging ear despite an intact tympanic membrane.Thepostoperative ear drum is seen to be red, glistening , discharging and intact,which causes endless trouble to the patient. This would sometimes also requirea revision surgery with excision of the mucous membrane.
In the underlay technique, the surgeon often would haveto lay a large volume of remnant tympanic membrane lateral to the graft. Proliferationand survival of tympanic membrane that is left laterally to graft createsisland of discharging mucous membrane. Another postulate for the dischargingtympanic membrane being that; mucous membrane grows at faster rate duringpostoperative healing than the epithelium, so that tympanic membrane has mucosaover the lateral surface.
The novel method aims to correct deficiencies of theunderlay technique, by excising the complete annulus of the remainingperforated tympanic membrane. The study aims to compare the graft uptake andimprovement of hearing in patients undergoing conventional tympanoplasty andthose undergoing total annulus excision.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic otitis media of the mucosal type with large, subtotal and total perforations.
- •Air bone gap in pure tone audiometry > 20 dB.
排除标准
- •1.Patients having active discharge at presentation 2.Patients having history of previous surgeries on the same side of planned operation 3.Patients having small central perforations 4.Age less than 18 years and more than 60 years 5.Patients having sensorineural component in Pure tone audiogram.
结局指标
主要结局
1.Graft uptake will be measured by otoscopy
时间窗: 2 weeks, 1 month and 3 months
2.Hearing gain will be measured by pure tone audiometry.
时间窗: 2 weeks, 1 month and 3 months
3.Quality of life assessment scores using questionnaire prepared by the investigator
时间窗: 2 weeks, 1 month and 3 months
( based on chronic ear survey by Massachusetts Eye and Ear)
时间窗: 2 weeks, 1 month and 3 months
次要结局
- quality of life assessment scores using questionnaire prepared by the investigator(( based on chronic ear survey by Massachusetts Eye and Ear))