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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholesteatoma; Tympanic Membrane Perforation; Otorrhea; Tympanosclerosis; Myringosclerosis; Serous Otitis; Retraction Pocket; Audiometric Tests

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Rémi MARIANOWSKI; Phone Number: +33 0298223378; Email: remi.marianowski@chu-brest.fr
• Study Contact Backup: Name: Solenn BIR; Email: solenn.bir@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals currently over 10 years old with an orofacial cleft (excluding isolated cleft lip).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Estimated): December 12, 2024
• Primary Completion (Estimated): December 12, 2024
• Study Completion (Estimated): December 12, 2024

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: cleft palate; ENT; Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma otorrhea Myringosclerosis Tympanosclerosis Audiometric tests; transtympanic ventilatory tubes.
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries; Skin Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Otorhinolaryngologic Diseases; Ear Diseases; Keratosis; Lip Diseases; Mouth Abnormalities; Tympanosclerosis; Cleft Lip; Otitis; Tympanic Membrane Perforation; Myringosclerosis; Cholesteatoma
• Other Study ID Numbers: 29BRC24.0229 - EFEOF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No