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

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

Study Overview

• Status: Completed
• Conditions: Tympanic Membrane Perforation; Tempanoplasty
• Intervention / Treatment: Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery

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.

• Study Type: Observational
• Enrollment (Actual): 980

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hospital Necker - Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 33 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric ENT Head and Neck Surgery, Necker hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children aged under 7 years old when tympanoplatie; Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery	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; Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery	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; Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery	Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Children aged over 14 years at the tympanoplatie; Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery	Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)	Closed eardrum; Abnormal eardrum perforation residual, ear effusion, progressive retraction cholesteatoma	12 months (range 9 to 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors influencing the functional outcome of the tympanoplasty	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.	12 months (range 9 to 18 months)
Factors influencing the functional outcome of the tympanoplasty	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.	36 months ( range 30 to 42 months)
Change anatomical result of the tympanoplasty		36 months ( range 30 to 42 months)
factors affecting the anatomical and functional results of the tympanoplasty.	clinical examination by pediatric ENT; hearing test	36 months ( range 30 to 42 months)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Françoise DENOYELLE, MD, PhD, Hospital Necker - Enfants Malades

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2015
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: November 18, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: cohort; tympanic membrane perforation; retrospective; Childrens; tempanoplasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Tympanic Membrane Perforation
• Other Study ID Numbers: 1798756

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No