Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child
NCT ID: NCT02296944
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
980 participants
OBSERVATIONAL
2015-01-06
2017-12-08
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Children aged under 7 years old when tympanoplatie
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Children aged 7 to 10 years at the tympanoplatie
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Children aged 11 to 14 years at the tympanoplatie
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Children aged over 14 years at the tympanoplatie
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Interventions
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Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Eligibility Criteria
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Inclusion Criteria
* Patient operated between early 1998 and late 2012
* Postoperative audiometry and otoscopy available between 9 and 18 months after surgery
Exclusion Criteria
* The holders of the parent or the patient has reached majority informed the doctor of their refusal to data collection.
3 Years
35 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Françoise DENOYELLE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Necker - Enfants Malades
Locations
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Hospital Necker - Enfants Malades
Paris, , France
Countries
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Other Identifiers
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1798756
Identifier Type: -
Identifier Source: org_study_id