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Clinical Trials/NCT02296944
NCT02296944
Completed
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country980 target enrollmentJanuary 6, 2015

Overview

Phase
N/A
Intervention
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Conditions
Tympanic Membrane Perforation
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
980
Locations
1
Primary Endpoint
anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2015
End Date
December 8, 2017
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

Children aged under 7 years old when tympanoplatie

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

Intervention: 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

Intervention: 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

Intervention: 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

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

Outcomes

Primary Outcomes

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

Time Frame: 12 months (range 9 to 18 months)

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

Secondary Outcomes

  • 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))

Study Sites (1)

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