Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma

NCT06246682 | Recruiting DMC

• 1 other identifier: Soh-Med-24-01-03MD
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Cholesteatoma of Attic; Cholesteatoma, Middle Ear

Keywords

cholesteatoma; Endoscopic ear surgery; mastoid process

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cholesteatoma removal by otoendoscope

OTHER

removal of the cholesteatoma in atticoantral region by otoendoscope

Procedure: Transcanal Endoscopic removal of atticoantral cholesteatoma

Interventions

Transcanal Endoscopic removal of atticoantral cholesteatoma PROCEDURE

removal of the cholesteatoma presented in the atticoantral region by otoendoscope

cholesteatoma removal by otoendoscope

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with primary acquired localized atticoantral cholesteatoma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

faculty of medicine Sohag university

Sohag, 1670005, Egypt

RECRUITING

Related 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.

  PMID: 23566903 BACKGROUND

• 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.

  PMID: 29342049 BACKGROUND

MeSH Terms

Conditions

Cholesteatoma, Middle Ear; Cholesteatoma

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• farghali Abdelrahman

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

farghali abdelrahman, master

CONTACT

01067063919; farghali_abdelaziz@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of otolaryngology sohag university

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 10, 2024
• Primary Completion: December 10, 2025
• Study Completion: March 22, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)