Endoscopic Tympanoplasty: Single Versus Double Flap Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Healing or graft take rate
研究概览
简要总结
Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.
- •dry perforation for at least 3 months.
排除标准
- •Recurrent perforation after previous myringoplasty.
- •Ossicular disruption or fixation.
- •immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
结局指标
主要结局
Healing or graft take rate
时间窗: 3 months after surgery
closure of tympanic membrane perforation
次要结局
未报告次要终点
研究者
Noha A.Elkholy
ORL-HNS Resident
Mansoura University
