Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child (PERFOPED)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Tempanoplasty; Tympanic Membrane Perforation

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

Study type: Observational

Funder types: Other

Identifiers

NCT02296944

1798756

Details and patient eligibility

About

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

Full 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.

Enrollment: 980 patients

Sex: All

Ages: 3 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

980 participants in 4 patient groups

Children aged under 7 years old when tympanoplatie

Description:

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

Treatment:

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

Children aged 7 to 10 years at the tympanoplatie

Description:

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

Treatment:

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

Children aged 11 to 14 years at the tympanoplatie

Description:

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

Treatment:

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

Children aged over 14 years at the tympanoplatie

Description:

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

Treatment:

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