An observational study in Serous Otitis, Tympanic Membrane Perforation and Retraction Pocket, sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by University Hospital, Brest · Observational
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.
53 studies on the registry are indexed under Tympanic Membrane Perforation; 14 are open to participants now.
Browse Tympanic Membrane Perforation studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals currently over 10 years old with an orofacial cleft (excluding isolated cleft lip).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: 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
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Dec 2024, 0 months later.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Tympanic Membrane Perforation →