NCT02296944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
980

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

October 22, 2014

Last Update Submit

January 2, 2026

Conditions

Tympanic Membrane PerforationTempanoplasty

Keywords

Childrenstempanoplastytympanic membrane perforationretrospectivecohort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Factors influencing the functional outcome of the tympanoplasty

    12 months (range 9 to 18 months)

  • Factors influencing the functional outcome of the tympanoplasty

    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.

    36 months ( range 30 to 42 months)

Study Arms (4)

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

Interventions

Collection of anatomical and functional results in the appearance of the tympanic membrane after surgeryOTHER
Children aged 11 to 14 years at the tympanoplatieChildren aged 7 to 10 years at the tympanoplatieChildren aged over 14 years at the tympanoplatieChildren aged under 7 years old when tympanoplatie

Eligibility Criteria

Age3 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric ENT Head and Neck Surgery, Necker hospital.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Necker - Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 33993647RESULT

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Study Officials

  • Françoise DENOYELLE, MD, PhD

    Hospital Necker - Enfants Malades

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2014

First Posted

November 21, 2014

Study Start

January 6, 2015

Primary Completion

December 8, 2017

Study Completion

December 8, 2017

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations

FR(1)