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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2020-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cholesteatoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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endoscopic transcanal tympanoplasty with attico-antrostomy

Group Type ACTIVE_COMPARATOR

endoscopic transcanal tympanoplasty with attico-antrostomy

Intervention Type PROCEDURE

Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac

endoscopic assisted canal wall up mastoidectomy

Group Type ACTIVE_COMPARATOR

endoscopic assisted canal wall up mastoidectomy

Intervention Type PROCEDURE

traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma

Interventions

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endoscopic transcanal tympanoplasty with attico-antrostomy

Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac

Intervention Type PROCEDURE

endoscopic assisted canal wall up mastoidectomy

traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma

Intervention Type PROCEDURE

Eligibility Criteria

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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