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NCT04959539 Clinical Trial

Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial

Cholesteatoma Clinical Trial

Official title:
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04959539
Other study ID # MS/17.05.161
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date May 30, 2020

Study information
Verified date July 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the main objective of the study is to compare endoscopic transcanal tympanoplasty with attico-antrostomy with endoscopic assisted canal wall up mastoidectomy in treatment of limited attic cholesteatoma.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Cases of cholesteatoma limited to the middle ear and/or attic but not extending beyond the posterior end of the lateral semicircular canal (LSCC) proved radiologically with computed tomography (CT) scan Exclusion Criteria: - Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• endoscopic transcanal tympanoplasty with attico-antrostomy
Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac
• endoscopic assisted canal wall up mastoidectomy
traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma

Locations
Country Name City State
Egypt ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University Mansoura ElDakahlia

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary eradication of attic cholesteatoma number of participants with no recurrence documented by second look surgery or MRI diffusion 6 months postoperative
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