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Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma

The Impact of Mastoid Condition and Ossicular Reconstruction on the Outcome of the Transcanal Endoscopic Management of Localized Atticoantral Cholesteatoma Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06246682
Enrollment
25
Registered
2024-02-07
Start date
2024-02-10
Completion date
2026-03-22
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesteatoma, Middle Ear, Cholesteatoma of Attic

Keywords

cholesteatoma, Endoscopic ear surgery, mastoid process

Brief summary

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

Detailed 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.

Interventions

PROCEDURETranscanal Endoscopic removal of atticoantral cholesteatoma

removal of the cholesteatoma presented in the atticoantral region by otoendoscope

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
recurrence of cholesteatoma after procedure according to mastoid conditionsix months postoperative after the proceduremeasurement of changes in recurrence rate of cholesteatoma after its removal according to different types of mastoid process

Countries

Egypt

Contacts

Primary Contactfarghali abdelrahman, master
farghali_abdelaziz@med.sohag.edu.eg01067063919

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026