Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma

NCT ID: NCT06246682

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-10
• Study Completion Date: 2026-03-22

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.

Conditions

Cholesteatoma of Attic; Cholesteatoma, Middle Ear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cholesteatoma removal by otoendoscope

removal of the cholesteatoma in atticoantral region by otoendoscope

Group Type: OTHER

Transcanal Endoscopic removal of atticoantral cholesteatoma

Intervention Type: PROCEDURE

removal of the cholesteatoma presented in the atticoantral region by otoendoscope

Interventions

Transcanal Endoscopic removal of atticoantral cholesteatoma

removal of the cholesteatoma presented in the atticoantral region by otoendoscope

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Farghaly Abdelrahman Mekki

Assistant lecturer of otolaryngology sohag university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

farghali Abdelrahman

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Locations

faculty of medicine Sohag university

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

farghali abdelrahman, master

Role: CONTACT

farghali_abdelaziz@med.sohag.edu.eg

01067063919 ext. +2

Facility Contacts

Arafat Mahmoud, MD

Role: primary

arfatmahmoud@med.sohag.edu.eg

01007642544 ext. +2

References

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.

Reference Type: BACKGROUND

PMID: 23566903 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29342049 (View on PubMed)

Other Identifiers

Soh-Med-24-01-03MD

Identifier Type: -

Identifier Source: org_study_id