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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.
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.
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| Measure | Description | 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 |
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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
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Individuals currently over 10 years old with an orofacial cleft (excluding isolated cleft lip).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rémi MARIANOWSKI | Contact | 0298223378 | +33 | remi.marianowski@chu-brest.fr |
| Solenn BIR | Contact | solenn.bir@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Brest | Brest | 29609 | France |
All collected data that underlie results in a publication
Data will be available beginning three years and ending fifteen years following the final study report completion
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
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| D002781 | Cholesteatoma |
| D063371 | Myringosclerosis |
| D000092163 | Tympanosclerosis |
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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