A PROSPECTIVE RANDOMIZED STUDY TO COMPARE SURGICAL OUTCOME USING WET AND DRY TEMPORALIS FASCIA GRAFT IN TYMPANOPLASTY TYPE I
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate and compare the surgical outcome of tympanoplasty type I using dry and wet temporalis fascia graft.
研究概览
简要总结
The aim of the study is to evaluateand compare the surgical outcome of tympanoplasty type I using dry and wettemporalis fascia graft with following objectives-
PrimaryObjective:
1. * Quality of lifemeasurements for patients with chronic suppurative otitis media using ChronicEar Survey questionnaire
2. * Tocompare the surgical outcome using dry and wet temporal fascia graft in type 1tympanoplasty for graft uptake, primaryclosure of perforation, recurrentand residual perforation.
3. * To compare audiological outcome using dry and wet temporal fasciagraft in type 1 tympanoplasty.
Secondaryobjective:
1. * Tocompare the total operation time and graft placement time using wetversus dry temporal fascia graft in type 1 tympanoplasty.
2. * Tofind out complications after tympanoplasty type I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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
- •Cases of chronic suppurative otitis media tubotympanic type with central perforation having no active discharge for a period of at least 6 weeks.
排除标准
- •1.Cholesteatoma and granulation 2.Cases of retraction pocket/atelectatic ear.
- •3.Ossicular chain immobility or defect in ossicles 4.Revision cases.
结局指标
主要结局
To evaluate and compare the surgical outcome of tympanoplasty type I using dry and wet temporalis fascia graft.
时间窗: To evaluate and compare the surgical outcome of tympanoplasty type I using dry and wet temporalis fascia graft.
次要结局
- To evaluate and compare the surgical outcome of tympanoplasty type I using dry and wet temporalis fascia graft.(The duration of study is of one year.)