NCT02296944

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 980 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 3 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tympanic Membrane Perforation
• Tempanoplasty

Interventions

Type	Name	Description
OTHER	Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery

Timeline

• Start date: 2015-01-06
• Primary completion: 2017-12-08
• Completion: 2017-12-08
• First posted: 2014-11-21
• Last updated: 2026-01-06

Locations

1 site across 1 country: France