Chronic Otitis MediaNCT04374266
Tegmen Defect Management During Mastoidectomy
An observational study of Chronic Otitis Media, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to discuss our clinical experience on the management of the tegmen defects which were revealed during the mastoidectomy surgeries. Read more about this study
- Who is it for?
- Ages 12 to 74 years
- Conditions the study is for
- Chronic Otitis Media
- What is being tested?
- physical examination, and computerized tomography
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2007to 1 Jan 2017
- 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 12 to 74 years
- All sexes
- Child, Adult, Older adult
Study population: underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.
Who may be able to join
- underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.
Who cannot join
- patients who did not come to follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Postoperative Radiologic Assessment and Long Term Results of Tegmen Defects During Mastoidectomy
In this study, we aimed to discuss our clinical experience on the management of the tegmen defects which were revealed during the mastoidectomy surgeries.
- Conditions
- Chronic Otitis Media
- Being tested
- physical examination, and computerized tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical examination, and computerized tomographyDiagnostic test
physical examination, and computerized tomography was performed during routine follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
defect size
decreased size of the defects were examined
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jan 2007
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmet mutlu, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374266
- Sponsor's protocol ID
- Tegmen defect
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Postoperative Radiologic Assessment and Long Term Results of Tegmen Defects During Mastoidectomy
- ClinicalTrials.gov ID
- NCT04374266
- Acronym / sponsor ID
- Tegmen defect
- Conditions
- Chronic Otitis Media
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 5 May 2020 (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.
In this study, we aimed to discuss our clinical experience on the management of the tegmen defects which were revealed during the mastoidectomy surgeries.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 74 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.
Key inclusion criteria (1 listed)
- underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.
Key exclusion criteria (1 listed)
- patients who did not come to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical examination, and computerized tomographyphysical examination, and computerized tomography was performed during routine follow-up | Diagnostic test | – |
Primary outcome
defect size
Time frame: a year
decreased size of the defects were examined
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Otitis Media, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 5 May 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
defect size (time frame: a year). 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 5 May 2020; AzTrials last refreshed its copy on 27 Oct 2026.