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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Serous Otitis Audiometric Tests Cholesteatoma Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Ear Diseases Jaw Abnormalities Jaw Diseases Keratosis Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Myringosclerosis Otorhinolaryngologic Diseases Otorrhea Retraction Pocket Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Stomatognathic System Abnormalities Tympanic Membrane Perforation Tympanosclerosis Wounds and Injuries

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.

Time frame: 01/01/2004 to 01/01/2014

Study contacts

Contact information is provided by the study sponsor or research team.

Rémi MARIANOWSKI

CONTACT

[email protected]

0298223378 ext. +33

Solenn BIR

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: EFEOF

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Dec 18, 2024
Registry last updated: Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed