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Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip) (EFEOF)

Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06738927
Acronym
EFEOF
Enrollment
500
Registered
2024-12-18
Start date
2024-12-12
Completion date
2024-12-12
Last updated
2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Audiometric Tests, Cholesteatoma, Myringosclerosis, Otorrhea, Retraction Pocket, Serous Otitis, Tympanic Membrane Perforation, Tympanosclerosis

Keywords

Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma otorrhea Myringosclerosis Tympanosclerosis Audiometric tests, ENT, transtympanic ventilatory tubes., cleft palate

Brief summary

Studies published on the placement of transtympanic ventilatory tubes in children with cleft palate show heterogeneous results, highlighting the need for a new study with strong statistical power and long-term follow-up to clarify the real benefits of this intervention. Mirashrafi (2022) and Maina (2022), for example, emphasize the current uncertainties regarding the management of otitis media with effusion in children with cleft palate. Mirashrafi conducted a study on 40 children and found no significant difference between those with a complete cleft palate and those with an incomplete cleft palate in terms of middle ear status after the placement of transtympanic ventilatory tubes. Maina, in an ongoing review, identified a lack of consensus on the optimal management of chronic otitis media with effusion, with outcomes being varied and often of low methodological quality. The absence of convincing evidence justifies the need for further research to establish clear guidelines. The objective is to study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.

Detailed description

The primary evaluation criterion will be ENT consultations: Tympanic examination: Anatomical analysis of the tympanic membrane, assessing the presence or absence of: Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma Otorrhea Myringosclerosis Tympanosclerosis Audiometric tests: Assessment of auditory results from bone and air conduction curves for frequencies ranging from 250 to 4000 Hz, with analysis at every 250 Hz.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Presence of a facial cleft between 2004 and 2014 Minor and adult patients Followed up by ENT services at the University Hospital of Brest or Marseille

Exclusion criteria

Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate Objection from one of the parents Isolated cleft lip No ENT follow-up

Design outcomes

Primary

MeasureTime frame
To study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.01/01/2004 to 01/01/2014

Countries

France

Contacts

Primary ContactRémi MARIANOWSKI
remi.marianowski@chu-brest.fr0298223378
Backup ContactSolenn BIR
solenn.bir@chu-brest.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026