Back to resultsEndoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
Primary Purpose
Cholesteatoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
endoscopic transcanal tympanoplasty with attico-antrostomy
endoscopic assisted canal wall up mastoidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholesteatoma
Eligibility Criteria
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
Sites / Locations
- ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
endoscopic transcanal tympanoplasty with attico-antrostomy
endoscopic assisted canal wall up mastoidectomy
Arm Description
Outcomes
Primary Outcome Measures
eradication of attic cholesteatoma
number of participants with no recurrence documented by second look surgery or MRI diffusion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04959539
Brief Title
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
Official Title
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholesteatoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endoscopic transcanal tympanoplasty with attico-antrostomy
Arm Type
Active Comparator
Arm Title
endoscopic assisted canal wall up mastoidectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
endoscopic transcanal tympanoplasty with attico-antrostomy
Intervention Description
Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac
Intervention Type
Procedure
Intervention Name(s)
endoscopic assisted canal wall up mastoidectomy
Intervention Description
traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma
Primary Outcome Measure Information:
Title
eradication of attic cholesteatoma
Description
number of participants with no recurrence documented by second look surgery or MRI diffusion
Time Frame
6 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
City
Mansoura
State/Province
ElDakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
34851451
Citation
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.
Results Reference
derived
Learn more about this trial
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
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