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Clinical Trials/NCT04959539
NCT04959539
Completed
N/A

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

Mansoura University1 site in 1 country40 target enrollmentJune 1, 2016
ConditionsCholesteatoma

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cholesteatoma
Sponsor
Mansoura University
Enrollment
40
Locations
1
Primary Endpoint
eradication of attic cholesteatoma
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
May 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Noha A.Elkholy

Principle investigator

Mansoura University

Eligibility Criteria

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

Outcomes

Primary Outcomes

eradication of attic cholesteatoma

Time Frame: 6 months postoperative

number of participants with no recurrence documented by second look surgery or MRI diffusion

Study Sites (1)

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