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Status unknownNCT04551612Updated Sep 17, 2020

Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma

An observational study in Cholesteatoma, Middle Ear, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-17.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years and older
Sex
All
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Study 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

Read the detailed description

Cholesteatoma has three Classical forms: (1) Congenital, primary or genuine cholesteatoma: occurs behind an intact tympanic membrane. Primary acquired cholesteatoma: looks like a limited diverticulum of the pars flaccida with little or no history of otorrhea. Secondary acquired cholesteatoma: develops with posterosuperior perforations in eardrum and expansion of the disease process into the antrum, mastoid, attic and middle ear. Granulation tissue, polyps and foul- smelling otorrhea are common findings in this type

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Conditions studied

  • Cholesteatoma, Middle Ear

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03

In context

Cholesteatoma

23 studies on the registry are indexed under Cholesteatoma; 5 are open to participants now.

This study's planned enrollment of 80 is close to the median of 73 across 14 observational studies indexed under Cholesteatoma.

Browse Cholesteatoma studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cholesteatoma in one ear

Inclusion criteria

  • All adults above the age of 18 presented to the Assiut university Clinic with

cholesteatoma will be included in the study.

Exclusion criteria

Exclusion Criteria:

  1. Patients with previous mastoid surgery
  2. Patients with Craniofacial anomalies or cleft lip and palate
  3. Pediatric populations ≤ 18 years old
  4. Patients with congenital ear anomalies
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with cholesteatoma

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

    Radiation: Multislice computed tomography temporal bone

Interventions

  • RadiationMultislice computed tomography temporal bone

    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

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What researchers measure

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

    Time frame: One year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04551612
Lead sponsor
Assiut University
Responsible party
Mariam Zakaria (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 16, 2020
Start date
Oct 1, 2020 (estimated)
Primary completion
Oct 1, 2021 (estimated)
Completion
Oct 1, 2022 (estimated)
Last update
Sep 17, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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