Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma

Evaluation of the Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma

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

Study Overview

• Status: Unknown
• Conditions: Cholesteatoma, Middle Ear
• Intervention / Treatment: Radiation: Multislice computed tomography temporal bone

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

• Study Type: Observational
• Enrollment (Anticipated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cholesteatoma in one ear

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with cholesteatoma; Patients with cholesteatoma in one ear that will compared with the other healthy one.	Radiation: Multislice 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Keratosis; Cholesteatoma; Cholesteatoma, Middle Ear
• Other Study ID Numbers: Patients with Cholesteatoma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No