Level of Middle Cranial Fossa Dura in Patients With Cholesteatoma

Cholesteatoma, Middle Ear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04551612
• Other study ID #: Patients with Cholesteatoma
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholesteatoma
• Cholesteatoma, Middle Ear

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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