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临床试验/NCT03922295
NCT03922295已完成不适用

Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Mansoura University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月24日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha A.Elkholy

ORL-HNS Resident

Mansoura University

研究点 (2)

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