A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pure tone audiometry
研究概览
简要总结
Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case of quiescent chronic otitis media still remains controversial. Hence this study has been undertaken to study the differences in the outcomes of the 2 surgical procedures performed for chronic otitis media in a randomized control design.
详细描述
Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 [30 cases in each group]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3.
Outcomes:
- Improvement of hearing
- Closure of tympanic perforation
- Recurrence of disease
- external ear canal stenosis
Tools for measurement of outcomes [before and after surgery]:
- Pure tone audiometry
- Impedance audiometry
- Otoendoscopy
- External ear canal dimensions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic tubotympanic otitis media in quiescent phase with intact ossicular chain -
排除标准
- •atticoantral otitis media
- •Specific otitis media
- •Sensorineural hearing loss
- •Fixed/Dislocated ossicular chain
- •Uncorrectable disease focus in nose/throat
- •Chronic otitis media in active phase
- •Chronic otitis media with complications
- •Extensive unresectable tympanosclerosis
结局指标
主要结局
Pure tone audiometry
Impedance audiometry
Otoendoscopy
External ear canal dimensions
次要结局
未报告次要终点