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临床试验/NCT04584073
NCT04584073Unknown不适用

Comparison Between the Fate of Secretory Otitis Media in Patients With Adenoids Hypertrophy Undergoing Adenoidectomy Alone or With Myringotomy or With Myringotomy and Tympanostomy Tube Application

Assiut University0 个研究点目标入组 150 人开始时间: 2020年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Tympanogram

研究概览

简要总结

This study aims to compare the fate of Secretory Otitis Media in patients with adenoids hypertrophy undergoing Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application

详细描述

Otitis media with effusion (OME) is one of the most common diseases during childhood . It is defined as collection of non-purulent effusion (mucoid or serous) in the middle ear space without signs of acute infection. It's synomus are serous otitis media, secretory otitis media or glue ear. Adenoid hypertrophy can cause mechanical obstruction of the Eustachian tube which plays an important role in the pathogenesis of OME.

Management of OME consisted of many varieties; 1- Auto inflation, 2- Medical treatment and 3- Surgical. Surgical treatment indicated in cases where the effusion does not resolve spontaneously or failed medical treatment for 3 months and the main purpose of surgery is to restore middle ear aeration. Treatment options are Adenoidectomy with or without Myringotomy or Myringotomy and Tympanostomy tube application.

The aim of this study is to compare the efficacy of each surgical option in management of otitis media with effusion. This study will be carried out in ENT department of Assiut university hospital on 150 child diagnosed as persistent otitis media with effusion due to adenoid enlargement and they will be categorized randomly into three groups (50 cases per each). Group I will undergo Adenoidectomy alone, group II will undergo Adenoidectomy and Myringotomy and group III will undergo Adenoidectomy and Myringotomy and Tympanostomy tube application. All patients will be subjected to full ENT examination and audiological evaluation. Postoperative evaluation will be done for all patients for 3 months through clinical and audiological evaluation.

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Any case presented with Secretory Otitis Media with adenoids hypertrophy with the following criteria
  • Age is between 3 to 17 years old
  • With or without chronic tonsillitis
  • conductive hearing loss
  • Recurrent upper respiratory tract infection
  • Dull tympanic membrane on otoscopy (absent cone of light), decreased mobility of tympanic membrane
  • Type B tympanogram on tympanometry
  • OME not responding to medical treatment for three months

排除标准

  • Patients with the following criteria will be excluded from the study
  • Previous Myringotomy with or without Tympanostomy Tube application
  • Previous adenoidectomy or tonsillectomy
  • Previous ear surgery, cleft palate, Down's syndrome, congenital malformation of the ear and cholesteatoma.

结局指标

主要结局

Tympanogram

时间窗: after 3 months of surgery

Tympanogram is test to measure the movement of tympanic membrane in response to changes in pressure.

Audiogram

时间窗: After 3 months of surgery

Audiogram is graph that shows hearing sensitivity

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

Ahmed Ayman Ahmed Mostafa Abokrisha

Resident

Assiut University

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