Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedFirst Submitted
Initial submission to the registry
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 13, 2021
CompletedJuly 16, 2021
July 1, 2021
3.7 years
July 2, 2021
July 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
eradication of attic cholesteatoma
number of participants with no recurrence documented by second look surgery or MRI diffusion
6 months postoperative
Study Arms (2)
endoscopic transcanal tympanoplasty with attico-antrostomy
ACTIVE COMPARATORendoscopic assisted canal wall up mastoidectomy
ACTIVE COMPARATORInterventions
Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac
traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Al Mansurah, ElDakahlia, 35516, Egypt
Related Publications (1)
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.
PMID: 34851451DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
July 2, 2021
First Posted
July 13, 2021
Study Start
June 1, 2016
Primary Completion
January 30, 2020
Study Completion
May 30, 2020
Last Updated
July 16, 2021
Record last verified: 2021-07