CholesteatomaNCT04959539
Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
A study testing endoscopic transcanal tympanoplasty with attico-antrostomy and endoscopic assisted canal wall up mastoidectomy in people with Cholesteatoma, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cholesteatoma
- What is being tested?
- endoscopic transcanal tympanoplasty with attico-antrostomy and endoscopic assisted canal wall up mastoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2016to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach
Trial locations and contacts
1 site in 1 country.
Egypt1 site
ORL-HNS department,Mansoura University Hospital, Faculty of Medicine, Mansoura University
Al Mansurah, ElDakahlia, 35516
About this study
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.
- Conditions
- Cholesteatoma
- Being tested
- endoscopic transcanal tympanoplasty with attico-antrostomy, endoscopic assisted canal wall up mastoidectomy
- Medical subject headings
- Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic transcanal tympanoplasty with attico-antrostomyProcedure or surgery
Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac
endoscopic assisted canal wall up mastoidectomyProcedure or surgery
traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma
| Study group | Role | What they receive |
|---|---|---|
| endoscopic transcanal tympanoplasty with attico-antrostomy | Active comparator | Not described Receives: Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy |
| endoscopic assisted canal wall up mastoidectomy | Active comparator | Not described Receives: Procedure: endoscopic assisted canal wall up mastoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication of attic cholesteatoma
number of participants with no recurrence documented by second look surgery or MRI diffusion
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Jun 2016
- Primary completion30 Jan 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholesteatomaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha A.Elkholy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959539
- Sponsor's protocol ID
- MS/17.05.161
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Transcanal Tympanoplasty With Attico-antrostomy Versus Endoscopic-assisted Canal Wall up Mastoidectomy in Management of Localized Cholesteatoma: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04959539
- Acronym / sponsor ID
- MS/17.05.161
- Conditions
- Cholesteatoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic transcanal tympanoplasty with attico-antrostomy | Active comparator | Procedure: endoscopic transcanal tympanoplasty with attico-antrostomy |
| endoscopic assisted canal wall up mastoidectomy | Active comparator | Procedure: endoscopic assisted canal wall up mastoidectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Cases in which cholesteatoma extended beyond the attic were excluded as being potentially beyond the limits of the TEES approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic transcanal tympanoplasty with attico-antrostomyTranscanal approach followed by atticotomy to remove the attic cholesteatoma sac | Procedure or surgery | endoscopic transcanal tympanoplasty with attico-antrostomy |
| endoscopic assisted canal wall up mastoidectomytraditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma | Procedure or surgery | endoscopic assisted canal wall up mastoidectomy |
Primary outcome
eradication of attic cholesteatoma
Time frame: 6 months postoperative
number of participants with no recurrence documented by second look surgery or MRI diffusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 34851451Moneir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic transcanal tympanoplasty with attico-antrostomy and endoscopic assisted canal wall up mastoidectomy in people with Cholesteatoma, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eradication of attic cholesteatoma (time frame: 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.