Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma

Cholesteatoma, Middle Ear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246682
• Other study ID #: Soh-Med-24-01-03MD
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2024
• Est. completion date: March 22, 2026

Study information

• Verified date: January 2024
• Source: Sohag University
• Contact: farghali abdelrahman, master
• Phone: 01067063919
• Email: farghali_abdelaziz[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 22, 2026
• Est. primary completion date: December 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholesteatoma
• Cholesteatoma, Middle Ear

Intervention

Procedure:
• Transcanal Endoscopic removal of atticoantral cholesteatoma
removal of the cholesteatoma presented in the atticoantral region by otoendoscope

Locations

Country	Name	City	State
Egypt	faculty of medicine Sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Marchioni D, Piccinini A, Alicandri-Ciufelli M, Presutti L. Endoscopic anatomy and ventilation of the epitympanum. Otolaryngol Clin North Am. 2013 Apr;46(2):165-78. doi: 10.1016/j.otc.2012.10.002. Epub 2012 Nov 27. — View Citation

Presutti L, Anschuetz L, Rubini A, Ruberto M, Alicandri-Ciufelli M, Dematte M, Caversaccio M, Marchioni D. The Impact of the Transcanal Endoscopic Approach and Mastoid Preservation on Recurrence of Primary Acquired Attic Cholesteatoma. Otol Neurotol. 2018 Apr;39(4):445-450. doi: 10.1097/MAO.0000000000001712. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of cholesteatoma after procedure according to mastoid condition	measurement of changes in recurrence rate of cholesteatoma after its removal according to different types of mastoid process	six months postoperative after the procedure