Clinical trial NCT06738927: Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip) (EFEOF)
Official title: Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Serous Otitis
Tympanic Membrane Perforation
Retraction Pocket
Cholesteatoma
Otorrhea
Myringosclerosis
Tympanosclerosis
Audiometric Tests
Keywords: Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma otorrhea Myringosclerosis Tympanosclerosis Audiometric tests
ENT
transtympanic ventilatory tubes.
cleft palate
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 500
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals currently over 10 years old with an orofacial cleft (excluding isolated cleft lip).

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.

Eligibility criteria: 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

Primary outcomes:
measure: To study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.
timeFrame: 01/01/2004 to 01/01/2014
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References: