CholesteatomaNCT06268938
Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery
A study testing Canal wall down tympanomastoidectomy in people with Cholesteatoma, run by Assiut University at 2 sites in Egypt.
Trial summary
Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery Read more about this study
- Who is it for?
- Ages 5 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholesteatoma
- What is being tested?
- Canal wall down tympanomastoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Sep 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- all patients who have extensive or recuutrent cholesteatoma undergoing canal wall down tympanomastoidectomy
Who cannot join
- not willing for surgery
- Malignancy
- Patients with intracranial complication
- Residual cholesteatoma
Trial locations and contacts
2 sites in 1 country.
About this study
Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery
Read the detailed description
Regarding discharge Time of epithelizqtion Hearing outcomes Quality of life
- Conditions
- Cholesteatoma
- Being tested
- Canal wall down tympanomastoidectomy
- Medical subject headings
- Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canal wall down tympanomastoidectomyProcedure or surgery
Mastoid cavity obliteration by in canal wall down tympanomastoidectomy tympanomastoidectomy in cholesteatoma surgery
| Study group | Role | What they receive |
|---|---|---|
| Muscle obliteration | Experimental | Mastoid cavity obliteration by muscle Receives: Procedure: Canal wall down tympanomastoidectomy |
| Bone obliteration | Active comparator | Mastoid cavity obliteration by bone Receives: Procedure: Canal wall down tympanomastoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of mastoid cavity in mm
Endoscopic examination of the mastoid cavity after 1month to evaluate the degree of epithelization and if there is discharge .
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start4 Sep 2023
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CholesteatomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abdelal Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268938
- Sponsor's protocol ID
- mastoid obliteration
- Status last verified
- Feb 2024
- First submitted
- 27 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mehta RP, Harris JP. Mastoid obliteration. Otolaryngol Clin North Am. 2006 Dec;39(6):1129-42. doi: 10.1016/j.otc.2006.08.007.
PubMed 17097437Khalil HS, Windle-Taylor PC. Canal wall down mastoidectomy: A long term commitment to the outpatients? BMC Ear Nose Throat Disord. 2003 Sep 4;3(1):1. doi: 10.1186/1472-6815-3-1.
PubMed 12956889Illes K, Meznerics FA, Dembrovszky F, Fehervari P, Banvolgyi A, Csupor D, Hegyi P, Horvath T. Mastoid Obliteration Decreases the Recurrent and Residual Disease: Systematic Review and Meta-analysis. Laryngoscope. 2023 Jun;133(6):1297-1305. doi: 10.1002/lary.30413. Epub 2022 Sep 28.
PubMed 36169349Krol B, Cywka KB, Skarzynska MB, Skarzynski PH. Mastoid obliteration with S53P4 bioactive glass after canal wall down mastoidectomy: Preliminary results. Am J Otolaryngol. 2021 Mar-Apr;42(2):102895. doi: 10.1016/j.amjoto.2020.102895. Epub 2021 Jan 5.
PubMed 33429176Weiss NM, Bachinger D, Botzen J, Grossmann W, Mlynski R. Mastoid cavity obliteration leads to a clinically significant improvement in health-related quality of life. Eur Arch Otorhinolaryngol. 2020 Jun;277(6):1637-1643. doi: 10.1007/s00405-020-05881-4. Epub 2020 Mar 6.
PubMed 32144569
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery
- ClinicalTrials.gov ID
- NCT06268938
- Acronym / sponsor ID
- mastoid obliteration
- Conditions
- Cholesteatoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 20 Feb 2024 (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.
Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery
Detailed description
Regarding discharge Time of epithelizqtion Hearing outcomes Quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle obliteration | Experimental | Procedure: Canal wall down tympanomastoidectomyMastoid cavity obliteration by muscle |
| Bone obliteration | Active comparator | Procedure: Canal wall down tympanomastoidectomyMastoid cavity obliteration by bone |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all patients who have extensive or recuutrent cholesteatoma undergoing canal wall down tympanomastoidectomy
Key exclusion criteria (4 listed)
- not willing for surgery
- Malignancy
- Residual cholesteatoma
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 |
|---|---|---|
| Canal wall down tympanomastoidectomyMastoid cavity obliteration by in canal wall down tympanomastoidectomy tympanomastoidectomy in cholesteatoma surgery | Procedure or surgery | Bone obliteration, Muscle obliteration |
Primary outcome
Size of mastoid cavity in mm
Time frame: 1 month
Endoscopic examination of the mastoid cavity after 1month to evaluate the degree of epithelization and if there is discharge .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 17097437Mehta RP, Harris JP. Mastoid obliteration. Otolaryngol Clin North Am. 2006 Dec;39(6):1129-42. doi: 10.1016/j.otc.2006.08.007.
- Background: PubMed 12956889Khalil HS, Windle-Taylor PC. Canal wall down mastoidectomy: A long term commitment to the outpatients? BMC Ear Nose Throat Disord. 2003 Sep 4;3(1):1. doi: 10.1186/1472-6815-3-1.
- Background: PubMed 36169349Illes K, Meznerics FA, Dembrovszky F, Fehervari P, Banvolgyi A, Csupor D, Hegyi P, Horvath T. Mastoid Obliteration Decreases the Recurrent and Residual Disease: Systematic Review and Meta-analysis. Laryngoscope. 2023 Jun;133(6):1297-1305. doi: 10.1002/lary.30413. Epub 2022 Sep 28.
- Background: PubMed 33429176Krol B, Cywka KB, Skarzynska MB, Skarzynski PH. Mastoid obliteration with S53P4 bioactive glass after canal wall down mastoidectomy: Preliminary results. Am J Otolaryngol. 2021 Mar-Apr;42(2):102895. doi: 10.1016/j.amjoto.2020.102895. Epub 2021 Jan 5.
- Background: PubMed 32144569Weiss NM, Bachinger D, Botzen J, Grossmann W, Mlynski R. Mastoid cavity obliteration leads to a clinically significant improvement in health-related quality of life. Eur Arch Otorhinolaryngol. 2020 Jun;277(6):1637-1643. doi: 10.1007/s00405-020-05881-4. Epub 2020 Mar 6.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canal wall down tympanomastoidectomy in people with Cholesteatoma, run by Assiut University at 2 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Size of mastoid cavity in mm (time frame: 1 month). 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 NCT06268938, which also lists 5 linked publications.
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 20 Feb 2024.