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

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

Study Overview

• Status: Recruiting
• Conditions: Cholesteatoma, Middle Ear; Cholesteatoma of Attic
• Intervention / Treatment: Procedure: Transcanal Endoscopic removal of 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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: farghali abdelrahman, master; Phone Number: +2 01067063919; Email: farghali_abdelaziz@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 1670005
    • Recruiting
    • faculty of medicine Sohag university
    • Contact: Arafat Mahmoud, MD; Phone Number: +2 01007642544; Email: arfatmahmoud@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: cholesteatoma removal by otoendoscope; removal of the cholesteatoma in atticoantral region by otoendoscope	Procedure: Transcanal Endoscopic removal of atticoantral cholesteatoma; removal of the cholesteatoma presented in the atticoantral region by otoendoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: farghali Abdelrahman, Sohag University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2024
• Primary Completion (Estimated): December 10, 2025
• Study Completion (Estimated): March 22, 2026

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopic ear surgery; cholesteatoma; mastoid process
• Additional Relevant MeSH Terms: Skin Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Keratosis; Cholesteatoma; Cholesteatoma, Middle Ear
• Other Study ID Numbers: Soh-Med-24-01-03MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No