跳至主要内容
临床试验/NCT00629694
NCT00629694已完成2 期

Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy

Aghia Sophia Children's Hospital of Athens1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2007年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
OM-6

研究概览

简要总结

It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far

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 (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age

排除标准

  • other health problems especially related with the condition eg cleft palate

结局指标

主要结局

OM-6

时间窗: one year post operative

次要结局

  • tympanogram type B(one year)

研究者

发起方
Aghia Sophia Children's Hospital of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ioannis Vlastos

MD

Aghia Sophia Children's Hospital of Athens

研究点 (1)

Loading locations...

相似试验