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临床试验/NCT02296944
NCT02296944已完成不适用

Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 980 人开始时间: 2015年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
980
试验地点
1
主要终点
anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)

研究概览

简要总结

This study is a retrospective cohort of patients minors during the operation of cartilage tympanoplasty for tympanic membrane perforation

详细描述

The investigators hypothesis is that the cartilage tympanoplastie lead to a closure of the tympanic membrane in 95% of cases. But the investigators believe that certain risk factors may influence the anatomical and functional results of tympanoplastie of the child and that their inclusion could improve these results.

For example, young age is not clear so far as a potential risk factor in the few studies analyzing this factor independently. A recommendation of the French Society of ENT surgery tympanic membrane perforation of the Child in 2006 recommended a minimum age of 6 years. However, the level of evidence of articles analyzed was small (it was basically a consensus of experts) and the investigators feel it necessary to study this factor by age (<7 years, 7-10 years, 11-14 years ,> 14 years) on a large cohort to determine the real influence of age on the anatomical and functional results as this may lead to changes in practice.

Similarly, whatever the influence of age in the general population, it could be a key criterion in children who have a particular field leading to prolonged tubal dysfunction (vélopalatines slots and craniofacial malformations), leading to raising the age of surgery tympanic closure: the investigators have for example in 1000 tympanoplasties for perforation, expected recruitment numbers in this study, 50 patients with craniofacial malformation or vélopalatine slot.

The purpose of this study is to investigate the factors influencing the anatomic outcome at one year of cartilage tympanoplastie child.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient minors during the operation of cartilage tympanoplasty for tympanic membrane perforation (tympanoplasty for this first ear)
  • Patient operated between early 1998 and late 2012
  • Postoperative audiometry and otoscopy available between 9 and 18 months after surgery

排除标准

  • History of tympanoplasty ipsilateral, tympanic membrane perforation associated with épidermose or cholesteatoma
  • The holders of the parent or the patient has reached majority informed the doctor of their refusal to data collection.

研究组 & 干预措施

Children aged under 7 years old when tympanoplatie

Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery

干预措施: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery (Other)

Children aged 7 to 10 years at the tympanoplatie

Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery

干预措施: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery (Other)

Children aged 11 to 14 years at the tympanoplatie

Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery

干预措施: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery (Other)

Children aged over 14 years at the tympanoplatie

Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery

干预措施: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery (Other)

结局指标

主要结局

anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)

时间窗: 12 months (range 9 to 18 months)

* Closed eardrum * Abnormal eardrum perforation residual, ear effusion, progressive retraction cholesteatoma

次要结局

  • Change anatomical result of the tympanoplasty(36 months ( range 30 to 42 months))
  • Factors influencing the functional outcome of the tympanoplasty(36 months ( range 30 to 42 months))
  • factors affecting the anatomical and functional results of the tympanoplasty.(36 months ( range 30 to 42 months))
  • Factors influencing the functional outcome of the tympanoplasty(12 months (range 9 to 18 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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