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

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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Key information

Conditions

Cholesteatoma Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University

Al Mansurah, ElDakahlia, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic transcanal tympanoplasty with attico-antrostomy

Procedure

Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac

endoscopic assisted canal wall up mastoidectomy

Procedure

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

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Jul 13, 2021
Registry last updated: Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed