Overview

This trial is active, not recruiting.

Conditions tympanic membrane perforation, tempanoplasty
Treatment collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Sponsor Assistance Publique - Hôpitaux de Paris
Start date January 2015
End date November 2017
Trial size 980 participants
Trial identifier NCT02296944, 1798756

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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
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
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
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

Primary Outcomes

Measure
anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)
time frame: 12 months (range 9 to 18 months)

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 3 years up to 35 years old.

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.

Additional Information

Official title Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child
Principal investigator Françoise DENOYELLE, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.