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NCT06268938 Clinical Trial

Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery

Cholesteatoma Clinical Trial

Official title:
Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06268938
Other study ID # mastoid obliteration
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date December 1, 2028

Study information
Verified date February 2024
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery

Description:

Regarding discharge Time of epithelizqtion Hearing outcomes Quality of life

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4
Est. completion date December 1, 2028
Est. primary completion date November 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 60 Years
Eligibility Inclusion Criteria: - all patients who have extensive or recuutrent cholesteatoma undergoing canal wall down tympanomastoidectomy Exclusion Criteria: - not willing for surgery - Malignancy - Patients with intracranial complication - Residual cholesteatoma

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Canal wall down tympanomastoidectomy
Mastoid cavity obliteration by in canal wall down tympanomastoidectomy tympanomastoidectomy in cholesteatoma surgery

Locations
Country Name City State
Egypt Assiut university hospital Assiut
Egypt Rehab Abd Elal Mohammed Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Illes K, Meznerics FA, Dembrovszky F, Fehervari P, Banvolgyi A, Csupor D, Hegyi P, Horvath T. Mastoid Obliteration Decreases the Recurrent and Residual Disease: Systematic Review and Meta-analysis. Laryngoscope. 2023 Jun;133(6):1297-1305. doi: 10.1002/lary.30413. Epub 2022 Sep 28. — View Citation

Khalil HS, Windle-Taylor PC. Canal wall down mastoidectomy: A long term commitment to the outpatients? BMC Ear Nose Throat Disord. 2003 Sep 4;3(1):1. doi: 10.1186/1472-6815-3-1. — View Citation

Krol B, Cywka KB, Skarzynska MB, Skarzynski PH. Mastoid obliteration with S53P4 bioactive glass after canal wall down mastoidectomy: Preliminary results. Am J Otolaryngol. 2021 Mar-Apr;42(2):102895. doi: 10.1016/j.amjoto.2020.102895. Epub 2021 Jan 5. — View Citation

Mehta RP, Harris JP. Mastoid obliteration. Otolaryngol Clin North Am. 2006 Dec;39(6):1129-42. doi: 10.1016/j.otc.2006.08.007. — View Citation

Weiss NM, Bachinger D, Botzen J, Grossmann W, Mlynski R. Mastoid cavity obliteration leads to a clinically significant improvement in health-related quality of life. Eur Arch Otorhinolaryngol. 2020 Jun;277(6):1637-1643. doi: 10.1007/s00405-020-05881-4. Epub 2020 Mar 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Size of mastoid cavity in mm Endoscopic examination of the mastoid cavity after 1month to evaluate the degree of epithelization and if there is discharge . 1 month
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