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

Tympanic Membrane Perforation Clinical Trial

— PERFOPED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296944
• Other study ID #: 1798756
• Status: Completed
• Phase: N/A
• First received: October 22, 2014
• Last updated: December 20, 2017
• Start date: January 6, 2015
• Est. completion date: December 8, 2017

Study information

• Verified date: December 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tempanoplasty
• Tympanic Membrane Perforation

Intervention

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

Locations

Country	Name	City	State
France	Hospital Necker - Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Change anatomical result of the tympanoplasty		36 months ( range 30 to 42 months)
Secondary	factors affecting the anatomical and functional results of the tympanoplasty.	clinical examination by pediatric ENT; hearing test	36 months ( range 30 to 42 months)