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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04959539
Enrollment
40
Registered
2021-07-13
Start date
2016-06-01
Completion date
2020-05-30
Last updated
2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholesteatoma

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.

Interventions

PROCEDUREendoscopic transcanal tympanoplasty with attico-antrostomy

Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac

PROCEDUREendoscopic assisted canal wall up mastoidectomy

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
eradication of attic cholesteatoma6 months postoperativenumber of participants with no recurrence documented by second look surgery or MRI diffusion

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026