- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04374266
Tegmen Defect Management During Mastoidectomy
May 1, 2020 updated by: ahmet mutlu, Istanbul Medeniyet University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kocaeli, Turkey
- Kocaeli University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 74 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.
Description
Inclusion Criteria:
- underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.
Exclusion Criteria:
- patients who did not come to follow up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
defect size
Time Frame: a year
|
decreased size of the defects were examined
|
a year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2007
Primary Completion (ACTUAL)
January 1, 2017
Study Completion (ACTUAL)
January 1, 2017
Study Registration Dates
First Submitted
May 1, 2020
First Submitted That Met QC Criteria
May 1, 2020
First Posted (ACTUAL)
May 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 5, 2020
Last Update Submitted That Met QC Criteria
May 1, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tegmen defect
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.