Serous OtitisEFEOFNCT06738927
Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip) (EFEOF)
An observational study of Serous Otitis and Tympanic Membrane Perforation, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Serous Otitis, Tympanic Membrane Perforation, Retraction Pocket
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2024to 12 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals currently over 10 years old with an orofacial cleft (excluding isolated cleft lip).
Who may be able to join
- 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
Who cannot join
- Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate Objection from one of the parents Isolated cleft lip No ENT follow-up
Trial locations and contacts
1 site in 1 country.
Solenn BIR contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Serous Otitis, Tympanic Membrane Perforation, Retraction Pocket, Cholesteatoma, Otorrhea, Myringosclerosis
- Keywords
- Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma otorrhea Myringosclerosis Tympanosclerosis Audiometric tests, ENT, transtympanic ventilatory tubes., cleft palate
- Medical subject headings
- Tympanic Membrane Perforation, Cholesteatoma, Myringosclerosis, Tympanosclerosis, Cleft Palate
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the otological status of patients based on the presence or absence of ENT surgical management involving the placement of transtympanic ventilatory tubes.
Measured: 01/01/2004 to 01/01/2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start12 Dec 2024 (estimated)
- Primary completion12 Dec 2024 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serous OtitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738927
- Sponsor's protocol ID
- 29BRC24.0229 - EFEOF
- Acronym
- EFEOF
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Otological Study of Facial Cleft Patients Over 10 Years of Age (Excluding Isolated Cleft Lip)
- ClinicalTrials.gov ID
- NCT06738927
- Acronym / sponsor ID
- EFEOF / 29BRC24.0229 - EFEOF
- Conditions
- Serous Otitis, Tympanic Membrane Perforation, Retraction Pocket, Cholesteatoma, Otorrhea, Myringosclerosis
- Keywords
- Serous otitis Tympanic membrane perforation Retraction pocket Cholesteatoma otorrhea Myringosclerosis Tympanosclerosis Audiometric tests, ENT, transtympanic ventilatory tubes., cleft palate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 Dec 2024 (estimated)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals currently over 10 years old with an orofacial cleft (excluding isolated cleft lip).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate Objection from one of the parents Isolated cleft lip No ENT follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Solenn BIR contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serous Otitis and Tympanic Membrane Perforation, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rémi MARIANOWSKI (0298223378 ext. +33, remi.marianowski@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.