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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02296944
Acronym
PERFOPED
Enrollment
980
Registered
2014-11-21
Start date
2015-01-06
Completion date
2017-12-08
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tempanoplasty, Tympanic Membrane Perforation

Keywords

Childrens, tempanoplasty, tympanic membrane perforation, retrospective, cohort

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.

Interventions

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

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)12 months (range 9 to 18 months)* Closed eardrum * Abnormal eardrum perforation residual, ear effusion, progressive retraction cholesteatoma

Secondary

MeasureTime frameDescription
Factors influencing the functional outcome of the tympanoplasty12 months (range 9 to 18 months)* mean bone conduction (BC) * air conduction (AC) * residual air-bone gap (RR = AC-BC). AC, BC and RR means are calculated on an average of four frequencies 0.5, 1, 2, 4 kHz Good functional outcome will be determined by an average RR ≤20 dB. A labyrinthisation be defined by a mean post-op compounded BC over 10 dB or moypostop BC - BC moypréop\> 10 dB.
Change anatomical result of the tympanoplasty36 months ( range 30 to 42 months)
factors affecting the anatomical and functional results of the tympanoplasty.36 months ( range 30 to 42 months)* clinical examination by pediatric ENT * hearing test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026