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Completed

NCT Number: NCT02296944

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

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

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Key information

Conditions

Tympanic Membrane Perforation Ear Diseases Otorhinolaryngologic Diseases Tempanoplasty Wounds and Injuries

Age range

3 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Necker - Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Primary outcomes

  1. anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)

    Time frame: 12 months (range 9 to 18 months)

    • Closed eardrum
    • Abnormal eardrum perforation residual, ear effusion, progressive retraction cholesteatoma

Secondary outcomes

  1. Factors influencing the functional outcome of the tympanoplasty

    Time frame: 12 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.

  2. Factors influencing the functional outcome of the tympanoplasty

    Time frame: 36 months ( range 30 to 42 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.

  3. Change anatomical result of the tympanoplasty

    Time frame: 36 months ( range 30 to 42 months)

  4. factors affecting the anatomical and functional results of the tympanoplasty.

    Time frame: 36 months ( range 30 to 42 months)

    • clinical examination by pediatric ENT
    • hearing test

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: PERFOPED

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2014
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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