Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma

Sohag University

Status: Enrolling

Conditions: Cholesteatoma, Middle Ear; Cholesteatoma of Attic

Treatments: Procedure: Transcanal Endoscopic removal of atticoantral cholesteatoma

Study type: Interventional

Funder types: Other

Identifiers

NCT06246682

Soh-Med-24-01-03MD

Details and patient eligibility

About

The goal of this interventional study is to learn about the effect of mastoid process status and the method of ossicular reconstruction on the results of the procedure transcanal endoscopic management of patients with localized atticoantral cholesteatoma

Full description

Acquired cholesteatoma is a special form of chronic otitis media in which keratinizing squamous epithelium grows from the tympanic membrane or/and the auditory canal skin into the middle ear mucosa. Acquired cholesteatomas of the middle ear are further divided into primary acquired and secondary acquired forms. The primary acquired cholesteatoma is the most frequent type of acquired cholesteatoma and develops by the progression of an initial retraction pocket into a cholesteatoma. Primary acquired cholesteatomas are named relative to the site of the pocket origin: (1) attic cholesteatoma consecutive to a pars flaccida pocket,(2) mesotympanic cholesteatoma due to a pars tensa pocket, and (3) combined forms, due to double pockets. The predominant form of acquired cholesteatoma in children develops in 80% from retraction pockets of the pars tensa whereas in adults, this form develops mainly in the pars flaccida.

The diagnosis of cholesteatoma is made on otoscopic examination, including endoscopic and microscopic evaluation, imaging, or surgical exploration. The symptoms of cholesteatoma vary; some cholesteatomas are asymptomatic, whereas others become infected and rapidly cause bone destruction. Some patients will present with slowly progressive conductive hearing loss and, frequently, with chronic otitis and purulent otorrhea. The otorrhea from an infected cholesteatoma often is malodorous because of the frequent infection with anaerobic bacteria. Some patients will have signs and symptoms of the complications of a cholesteatoma: vertigo and hearing loss caused by a labyrinthine fistula, facial nerve paralysis, or intracranial infection.

there are some contraindications to the use of exclusively endoscopic approaches. For example, if cholesteatoma involves the mastoid cavity, it is not possible to control and remove it by only a transcanal approach; the use of the microscope in combination with the endoscope is recommended. Also, a narrow external ear canal, or external ear malformation, can pose general anatomical difficulties for exclusively endoscopic approaches.

Enrollment: 25 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with primary acquired localized atticoantral cholesteatoma.

Exclusion criteria

• Age group: patients below 12 years old.
• Patients presenting with congenital or secondary acquired cholesteatoma.
• Patients presenting with extensive, residual, or recurrent cholesteatoma.
• Patients with craniofacial anomalies.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

cholesteatoma removal by otoendoscope

Other group

Description:

removal of the cholesteatoma in atticoantral region by otoendoscope

Treatment:

Procedure: Transcanal Endoscopic removal of atticoantral cholesteatoma