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

Not Applicable

Completed

• Conditions: Cholesteatoma
• Interventions: Procedure: endoscopic assisted canal wall up mastoidectomy; Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy

• Registration Number: NCT04959539
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2020-01-30
• Study Completion: 2020-05-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-12
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endoscopic assisted canal wall up mastoidectomy	endoscopic assisted canal wall up mastoidectomy	-
endoscopic transcanal tympanoplasty with attico-antrostomy	endoscopic transcanal tympanoplasty with attico-antrostomy	-

Primary Outcome Measures

Name	Time	Method
eradication of attic cholesteatoma	6 months postoperative	number of participants with no recurrence documented by second look surgery or MRI diffusion

Trial Locations

Locations (1)

ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, ElDakahlia, Egypt