Tympanic Membrane PerforationPERFOPEDNCT02296944
Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child
An observational study of Tympanic Membrane Perforation and Tempanoplasty, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study is a retrospective cohort of patients minors during the operation of cartilage tympanoplasty for tympanic membrane perforation Read more about this study
- Who is it for?
- Ages 3 to 35 years
- Conditions the study is for
- Tympanic Membrane Perforation, Tempanoplasty
- What is being tested?
- Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
- How many people
- 980 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2015to 8 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric ENT Head and Neck Surgery, Necker hospital.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
This study is a retrospective cohort of patients minors during the operation of cartilage tympanoplasty for tympanic membrane perforation
Read the 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.
- Conditions
- Tympanic Membrane Perforation, Tempanoplasty
- Being tested
- Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
- Keywords
- Childrens, tempanoplasty, tympanic membrane perforation, retrospective, cohort
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of anatomical and functional results in the appearance of the tympanic membrane after surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Children aged under 7 years old when tympanoplatie | Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery Receives: 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 Receives: 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 Receives: 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 Receives: Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery)
- Closed eardrum
- Abnormal eardrum perforation residual, ear effusion, progressive retraction cholesteatoma
Measured: 12 months (range 9 to 18 months)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 36 months ( range 30 to 42 months)
Change anatomical result of the tympanoplasty
Measured: 36 months ( range 30 to 42 months)
factors affecting the anatomical and functional results of the tympanoplasty.
- clinical examination by pediatric ENT
- hearing test
Measured: 36 months ( range 30 to 42 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study start6 Jan 2015
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 980 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Françoise DENOYELLE, MD, PhD, Principal investigator, Hospital Necker - Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296944
- Sponsor's protocol ID
- 1798756
- Acronym
- PERFOPED
- Status last verified
- Dec 2025
- First submitted
- 22 Oct 2014
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Simon F, Thierry B, Rabeony T, Verrier F, Elie C, Loundon N, Leboulanger N, Couloigner V, Garabedian EN, Denoyelle F. Long-term outcomes of cartilage tympanoplasty in 139 ears in children. Clin Otolaryngol. 2021 Nov;46(6):1395-1399. doi: 10.1111/coa.13801. Epub 2021 May 31. No abstract available.
PubMed 33993647
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child
- ClinicalTrials.gov ID
- NCT02296944
- Acronym / sponsor ID
- PERFOPED / 1798756
- Conditions
- Tympanic Membrane Perforation, Tempanoplasty
- Keywords
- Childrens, tempanoplasty, tympanic membrane perforation, retrospective, cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 980 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Jan 2015 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children aged under 7 years old when tympanoplatie | – | Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgeryCollection of anatomical and functional results in the appearance of the tympanic membrane after surgery |
| Children aged 7 to 10 years at the tympanoplatie | – | Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgeryCollection of anatomical and functional results in the appearance of the tympanic membrane after surgery |
| Children aged 11 to 14 years at the tympanoplatie | – | Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgeryCollection of anatomical and functional results in the appearance of the tympanic membrane after surgery |
| Children aged over 14 years at the tympanoplatie | – | Other: Collection of anatomical and functional results in the appearance of the tympanic membrane after surgeryCollection of anatomical and functional results in the appearance of the tympanic membrane after surgery |
Who may qualify
- Ages
- 3 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric ENT Head and Neck Surgery, Necker hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery | Other | Children aged 11 to 14 years at the tympanoplatie, Children aged 7 to 10 years at the tympanoplatie, Children aged over 14 years at the tympanoplatie, Children aged under 7 years old when tympanoplatie |
Primary outcome
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
4 secondary outcomes
Factors influencing the functional outcome of the tympanoplasty
Time frame: 12 months (range 9 to 18 months)
Factors influencing the functional outcome of the tympanoplasty
Time frame: 36 months ( range 30 to 42 months)
Change anatomical result of the tympanoplasty
Time frame: 36 months ( range 30 to 42 months)
factors affecting the anatomical and functional results of the tympanoplasty.
Time frame: 36 months ( range 30 to 42 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 33993647Simon F, Thierry B, Rabeony T, Verrier F, Elie C, Loundon N, Leboulanger N, Couloigner V, Garabedian EN, Denoyelle F. Long-term outcomes of cartilage tympanoplasty in 139 ears in children. Clin Otolaryngol. 2021 Nov;46(6):1395-1399. doi: 10.1111/coa.13801. Epub 2021 May 31. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise DENOYELLE, MD, PhD principal investigator
Hospital Necker - Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanic Membrane Perforation and Tempanoplasty, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anatomical result of the appearance of the tympanoplasty (tympanic membrane perforation after surgery) (time frame: 12 months (range 9 to 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.