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

Not yet recruiting

• Conditions: Serous Otitis; Tympanic Membrane Perforation; Retraction Pocket; Cholesteatoma; Otorrhea; Myringosclerosis; Tympanosclerosis; Audiometric Tests

• Registration Number: NCT06738927
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-12-12
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chu Brest; 🇫🇷 Brest, France