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CompletedNCT04959539Updated Jul 16, 2021

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

An interventional study of endoscopic transcanal tympanoplasty with attico-antrostomy and endoscopic assisted canal wall up mastoidectomy in Cholesteatoma, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-07-16.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 1 month after the study started (first participant enrolled Jun 2016, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

02

Conditions studied

  • Cholesteatoma

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03

In context

Cholesteatoma

23 studies on the registry are indexed under Cholesteatoma; 5 are open to participants now.

Browse Cholesteatoma studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    endoscopic transcanal tympanoplasty with attico-antrostomy

    Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy

  • Active comparator
    endoscopic assisted canal wall up mastoidectomy

    Procedure: endoscopic assisted canal wall up mastoidectomy

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

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What researchers measure

Primary outcomes

  1. eradication of attic cholesteatoma

    number of participants with no recurrence documented by second look surgery or MRI diffusion

    Time frame: 6 months postoperative

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Study locations

1 site
  • ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
    Mansoura, ElDakahlia 35516, Egypt
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References and documents

Publications

  • Moneir W, Hemdan A, El-Kholy NA, El-Kotb M, El-Okda M. Endoscopic transcanal attico-antrostomy versus endoscopic-assisted canal wall up mastoidectomy in management of localized cholesteatoma: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2022 Sep;279(9):4371-4378. doi: 10.1007/s00405-021-07200-x. Epub 2021 Dec 1. PubMed 34851451 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04959539
Lead sponsor
Mansoura University
Responsible party
Noha A.Elkholy (Principle investigator, Mansoura University) — Principal investigator
First posted
Jul 13, 2021
Start date
Jun 1, 2016
Primary completion
Jan 30, 2020
Completion
May 30, 2020
Last update
Jul 16, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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