Clinical trial NCT02296944: Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child
Official title: Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tympanic Membrane Perforation
Tempanoplasty
Keywords: Childrens
tempanoplasty
tympanic membrane perforation
retrospective
cohort
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 980
Sex: ALL
Minimum age (years): 3
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric ENT Head and Neck Surgery, Necker hospital.

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.

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.

Primary outcomes:
measure: anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)
timeFrame: 12 months (range 9 to 18 months)
Secondary outcomes:
measure: Factors influencing the functional outcome of the tympanoplasty
timeFrame: 12 months (range 9 to 18 months)
measure: Factors influencing the functional outcome of the tympanoplasty
timeFrame: 36 months ( range 30 to 42 months)
measure: Change anatomical result of the tympanoplasty
timeFrame: 36 months ( range 30 to 42 months)
measure: factors affecting the anatomical and functional results of the tympanoplasty.
timeFrame: 36 months ( range 30 to 42 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Necker - Enfants Malades
Study officials:
affiliation: Hospital Necker - Enfants Malades
name: Françoise DENOYELLE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: