NCT04374266

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

10 years

First QC Date

May 1, 2020

Last Update Submit

May 1, 2020

Conditions

Chronic Otitis Media

Outcome Measures

Primary Outcomes (1)

  • defect size

    decreased size of the defects were examined

    a year

Interventions

physical examination, and computerized tomographyDIAGNOSTIC_TEST

physical examination, and computerized tomography was performed during routine follow-up

Eligibility Criteria

Age12 Years - 74 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • underwent mastoidectomy as alone or as a part of the surgery, and noticed tegmen mastoideum or tympani defect in related department.

You may not qualify if:

  • patients who did not come to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Physical ExaminationTomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisImage Interpretation, Computer-AssistedDiagnostic ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 5, 2020

Study Start

January 1, 2007

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations

TU(1)