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

NCT06738927 | Not Yet Recruiting

• 1 other identifier: 29BRC24.0229 - EFEOF
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Tympanic Membrane Perforation; Cholesteatoma; Myringosclerosis; Tympanosclerosis; Cleft Palate

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Rémi MARIANOWSKI

CONTACT

0298223378; remi.marianowski@chu-brest.fr

Solenn BIR

CONTACT

solenn.bir@chu-brest.fr

Study Design

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

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: December 12, 2024
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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

Locations

FR (1)