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

M

Mansoura University

Status

Completed

Conditions

Cholesteatoma

Treatments

Procedure: endoscopic assisted canal wall up mastoidectomy
Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04959539
MS/17.05.161

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

endoscopic transcanal tympanoplasty with attico-antrostomy
Active Comparator group
Treatment:
Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy
endoscopic assisted canal wall up mastoidectomy
Active Comparator group
Treatment:
Procedure: endoscopic assisted canal wall up mastoidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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