Cholesteatoma of AtticNCT06246682
Impact of Mastoid Condition on Results of Endoscopic Management of Cholesteatoma
A study testing Transcanal Endoscopic removal of atticoantral cholesteatoma in people with Cholesteatoma of Attic and Cholesteatoma, Middle Ear, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this interventional study is to learn about the effect of mastoid process status and the method of ossicular reconstruction on the results of the procedure transcanal endoscopic management of patients with localized atticoantral cholesteatoma Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cholesteatoma of Attic, Cholesteatoma, Middle Ear
- What is being tested?
- Transcanal Endoscopic removal of atticoantral cholesteatoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 22 Mar 2026
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting with primary acquired localized atticoantral cholesteatoma.
Who cannot join
- Age group: patients below 12 years old.
- Patients presenting with congenital or secondary acquired cholesteatoma.
- Patients presenting with extensive, residual, or recurrent cholesteatoma.
- Patients with craniofacial anomalies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine Sohag university
Sohag, 1670005
Arafat Mahmoud, MD, 01007642544 ext. +2, arfatmahmoud@med.sohag.edu.eg
About this study
Official title: The Impact of Mastoid Condition and Ossicular Reconstruction on the Outcome of the Transcanal Endoscopic Management of Localized Atticoantral Cholesteatoma Patients
The goal of this interventional study is to learn about the effect of mastoid process status and the method of ossicular reconstruction on the results of the procedure transcanal endoscopic management of patients with localized atticoantral cholesteatoma
Read the detailed description
Acquired cholesteatoma is a special form of chronic otitis media in which keratinizing squamous epithelium grows from the tympanic membrane or/and the auditory canal skin into the middle ear mucosa. Acquired cholesteatomas of the middle ear are further divided into primary acquired and secondary acquired forms. The primary acquired cholesteatoma is the most frequent type of acquired cholesteatoma and develops by the progression of an initial retraction pocket into a cholesteatoma. Primary acquired cholesteatomas are named relative to the site of the pocket origin: (1) attic cholesteatoma consecutive to a pars flaccida pocket,(2) mesotympanic cholesteatoma due to a pars tensa pocket, and (3) combined forms, due to double pockets. The predominant form of acquired cholesteatoma in children develops in 80% from retraction pockets of the pars tensa whereas in adults, this form develops mainly in the pars flaccida.
The diagnosis of cholesteatoma is made on otoscopic examination, including endoscopic and microscopic evaluation, imaging, or surgical exploration. The symptoms of cholesteatoma vary; some cholesteatomas are asymptomatic, whereas others become infected and rapidly cause bone destruction. Some patients will present with slowly progressive conductive hearing loss and, frequently, with chronic otitis and purulent otorrhea. The otorrhea from an infected cholesteatoma often is malodorous because of the frequent infection with anaerobic bacteria. Some patients will have signs and symptoms of the complications of a cholesteatoma: vertigo and hearing loss caused by a labyrinthine fistula, facial nerve paralysis, or intracranial infection.
there are some contraindications to the use of exclusively endoscopic approaches. For example, if cholesteatoma involves the mastoid cavity, it is not possible to control and remove it by only a transcanal approach; the use of the microscope in combination with the endoscope is recommended. Also, a narrow external ear canal, or external ear malformation, can pose general anatomical difficulties for exclusively endoscopic approaches.
- Conditions
- Cholesteatoma of Attic, Cholesteatoma, Middle Ear
- Being tested
- Transcanal Endoscopic removal of atticoantral cholesteatoma
- Keywords
- cholesteatoma, Endoscopic ear surgery, mastoid process
- Medical subject headings
- Cholesteatoma, Middle Ear, Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcanal Endoscopic removal of atticoantral cholesteatomaProcedure or surgery
removal of the cholesteatoma presented in the atticoantral region by otoendoscope
| Study group | Role | What they receive |
|---|---|---|
| cholesteatoma removal by otoendoscope | Other | removal of the cholesteatoma in atticoantral region by otoendoscope Receives: Procedure: Transcanal Endoscopic removal of atticoantral cholesteatoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of cholesteatoma after procedure according to mastoid condition
measurement of changes in recurrence rate of cholesteatoma after its removal according to different types of mastoid process
Measured: six months postoperative after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start10 Feb 2024 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion22 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cholesteatoma of AtticStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farghaly Abdelrahman Mekki, Sohag University
- Investigators
- farghali Abdelrahman, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246682
- Sponsor's protocol ID
- Soh-Med-24-01-03MD
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marchioni D, Piccinini A, Alicandri-Ciufelli M, Presutti L. Endoscopic anatomy and ventilation of the epitympanum. Otolaryngol Clin North Am. 2013 Apr;46(2):165-78. doi: 10.1016/j.otc.2012.10.002. Epub 2012 Nov 27.
PubMed 23566903Presutti L, Anschuetz L, Rubini A, Ruberto M, Alicandri-Ciufelli M, Dematte M, Caversaccio M, Marchioni D. The Impact of the Transcanal Endoscopic Approach and Mastoid Preservation on Recurrence of Primary Acquired Attic Cholesteatoma. Otol Neurotol. 2018 Apr;39(4):445-450. doi: 10.1097/MAO.0000000000001712.
PubMed 29342049
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mastoid Condition and Ossicular Reconstruction on the Outcome of the Transcanal Endoscopic Management of Localized Atticoantral Cholesteatoma Patients
- ClinicalTrials.gov ID
- NCT06246682
- Acronym / sponsor ID
- Soh-Med-24-01-03MD
- Conditions
- Cholesteatoma of Attic, Cholesteatoma, Middle Ear
- Keywords
- cholesteatoma, Endoscopic ear surgery, mastoid process
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 22 Mar 2026 (estimated)
- First posted
- 7 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.
The goal of this interventional study is to learn about the effect of mastoid process status and the method of ossicular reconstruction on the results of the procedure transcanal endoscopic management of patients with localized atticoantral cholesteatoma
Detailed description
Acquired cholesteatoma is a special form of chronic otitis media in which keratinizing squamous epithelium grows from the tympanic membrane or/and the auditory canal skin into the middle ear mucosa. Acquired cholesteatomas of the middle ear are further divided into primary acquired and secondary acquired forms. The primary acquired cholesteatoma is the most frequent type of acquired cholesteatoma and develops by the progression of an initial retraction pocket into a cholesteatoma. Primary acquired cholesteatomas are named relative to the site of the pocket origin: (1) attic cholesteatoma consecutive to a pars flaccida pocket,(2) mesotympanic cholesteatoma due to a pars tensa pocket, and (3) combined forms, due to double pockets. The predominant form of acquired cholesteatoma in children develops in 80% from retraction pockets of the pars tensa whereas in adults, this form develops mainly in the pars flaccida.
The diagnosis of cholesteatoma is made on otoscopic examination, including endoscopic and microscopic evaluation, imaging, or surgical exploration. The symptoms of cholesteatoma vary; some cholesteatomas are asymptomatic, whereas others become infected and rapidly cause bone destruction. Some patients will present with slowly progressive conductive hearing loss and, frequently, with chronic otitis and purulent otorrhea. The otorrhea from an infected cholesteatoma often is malodorous because of the frequent infection with anaerobic bacteria. Some patients will have signs and symptoms of the complications of a cholesteatoma: vertigo and hearing loss caused by a labyrinthine fistula, facial nerve paralysis, or intracranial infection.
there are some contraindications to the use of exclusively endoscopic approaches. For example, if cholesteatoma involves the mastoid cavity, it is not possible to control and remove it by only a transcanal approach; the use of the microscope in combination with the endoscope is recommended. Also, a narrow external ear canal, or external ear malformation, can pose general anatomical difficulties for exclusively endoscopic approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cholesteatoma removal by otoendoscope | Other | Procedure: Transcanal Endoscopic removal of atticoantral cholesteatomaremoval of the cholesteatoma in atticoantral region by otoendoscope |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with primary acquired localized atticoantral cholesteatoma.
Key exclusion criteria (4 listed)
- Age group: patients below 12 years old.
- Patients presenting with congenital or secondary acquired cholesteatoma.
- Patients presenting with extensive, residual, or recurrent cholesteatoma.
- Patients with craniofacial anomalies.
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 |
|---|---|---|
| Transcanal Endoscopic removal of atticoantral cholesteatomaremoval of the cholesteatoma presented in the atticoantral region by otoendoscope | Procedure or surgery | cholesteatoma removal by otoendoscope |
Primary outcome
recurrence of cholesteatoma after procedure according to mastoid condition
Time frame: six months postoperative after the procedure
measurement of changes in recurrence rate of cholesteatoma after its removal according to different types of mastoid process
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 23566903Marchioni D, Piccinini A, Alicandri-Ciufelli M, Presutti L. Endoscopic anatomy and ventilation of the epitympanum. Otolaryngol Clin North Am. 2013 Apr;46(2):165-78. doi: 10.1016/j.otc.2012.10.002. Epub 2012 Nov 27.
- Background: PubMed 29342049Presutti L, Anschuetz L, Rubini A, Ruberto M, Alicandri-Ciufelli M, Dematte M, Caversaccio M, Marchioni D. The Impact of the Transcanal Endoscopic Approach and Mastoid Preservation on Recurrence of Primary Acquired Attic Cholesteatoma. Otol Neurotol. 2018 Apr;39(4):445-450. doi: 10.1097/MAO.0000000000001712.
- Individual participant dataSharing planned: No
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.
farghali Abdelrahman principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcanal Endoscopic removal of atticoantral cholesteatoma in people with Cholesteatoma of Attic and Cholesteatoma, Middle Ear, run by Sohag 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 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: status not confirmed, as of the sponsor's last update on 7 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact farghali abdelrahman, master (01067063919 ext. +2, farghali_abdelaziz@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of cholesteatoma after procedure according to mastoid condition (time frame: six months postoperative after the procedure). 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 NCT06246682, which also lists 2 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 7 Feb 2024.