NCT04551612

Brief Summary

Cholesteatoma is a destructive lesion that progressively expands in the middle ear, mastoid or petrous bone and leads to destruction of the nearby structures. Erosion, which is caused by bone resorption of the ossicular chain and otic capsule, may cause hearing loss, vestibular dysfunction, facial paralysis and intracranial manifestations

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Status
unknown

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

First Submitted

Initial submission to the registry

September 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 10, 2020

Last Update Submit

September 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the Level of Middle Cranial Fossa Dura in Patients with Cholesteatoma by multislice computed tomography.

    determination the level of tegmen in patients with attico-antral diseases by MSCT

    One year

Study Arms (1)

Patients with cholesteatoma

Patients with cholesteatoma in one ear that will compared with the other healthy one.

Radiation: Multislice computed tomography temporal bone

Interventions

Patients with cholesteatoma will undergo multislice computed tomography (MSCT) temporal bone images. Then The Tegmen level will be determined and compared with the other normal ear at the same patient

Patients with cholesteatoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cholesteatoma in one ear

You may qualify if:

  • All adults above the age of 18 presented to the Assiut university Clinic with
  • cholesteatoma will be included in the study.

You may not qualify if:

  • Patients with previous mastoid surgery
  • Patients with Craniofacial anomalies or cleft lip and palate
  • Pediatric populations ≤ 18 years old
  • Patients with congenital ear anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholesteatoma, Middle Ear

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesCholesteatomaKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 16, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

September 17, 2020

Record last verified: 2020-09