Paediatric CholesteatomaNCT05584891
Radical Mastoidectomy Versus Mastoid Oblitration in Pediatric Population
An observational study of Paediatric Cholesteatoma, run by Assiut University at 1 site in Egypt.
Trial summary
Chronic otitis media (COM) has a significant impact on health issues since prehistoric time. It is a global disease, seen in all the continents of world having different environmental and socioeconomic background. Read more about this study
- Who is it for?
- Ages 2 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Paediatric Cholesteatoma
- What is being tested?
- mastoidectomy and mastoid oblitration
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2023to 30 Oct 2025
- Phase
- Observational
- 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 2 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: peadeatric population
Who may be able to join
- 1. Patient suffering from chronic suppurative otitis media, attico-antral (squamous) disease.
- 2. Age less than or equal to 18 years.
Who cannot join
- 1. Patient having an intracranial complication of chronic suppurative otitis media.
- 2. Bony erosion of sinus plate or dural plate or bone covering the Trautmann's triangle with granulations over the erosion in patients undergoing mastoid obliteration operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Radical Mastoidectomy With and Without Mastoid Obliteration Operations in Pediatric Population
Chronic otitis media (COM) has a significant impact on health issues since prehistoric time. It is a global disease, seen in all the continents of world having different environmental and socioeconomic background. COM is characterized as a permanent abnormality of the pars tensa or flaccida, most likely a result of earlier acute otitis media, negative middle ear pressure or otitis media with effusion. COM squamous active (cholesteatoma) is a type of COM, which is a mass formed by keratinizing squamous epithelium in the middle ear and/or mastoid, subepithelial connective tissue and by the progressive accumulation of keratin debris with/without surrounding inflammatory reaction.
Read the detailed description
Paediatric cholesteatoma spread more extensively through the temporal bone than in adult as the temporal bone in children is well pneumatized. The disease in children is frequently more extensive and expanding, with more involvement of the peri-labyrinthine cells and petrous apex. It is a commonly encountered disease entity which requires prompt surgical management as early as possible. The management of cholesteatoma is solely surgical.
Comparatively the pediatric population has higher rates of recurrent and residual disease, possibly due to anatomic and physiologic differences. Eustachian tube anatomy and dysfunction predisposes children to more frequent infections and retraction pockets. Thus posing a greater challenge than in adults in treating cholesteatom.
The goals of surgery are to eliminate epithelial and bone disease thoroughly and prevent the recurrence, produce a dry and safe ear and to restore serviceable hearing
- Conditions
- Paediatric Cholesteatoma
- Being tested
- mastoidectomy and mastoid oblitration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mastoidectomy and mastoid oblitrationProcedure or surgery
Forty pediatric patients with cholesteatoma indicated for radical mastoidectomy or modified radical mastoidectomies will be enrolled in our study and we will be grouped into two groups: one will undergo radical mastoidectomy alone and their operation results will be compared to other group which includes twenty pediatric patients with mastoid obliteration operation.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | radical mastoidectomy Receives: Procedure: mastoidectomy and mastoid oblitration | |
| group2 | mastoid obliteration operation. Receives: Procedure: mastoidectomy and mastoid oblitration |
What is being measured
The primary outcome is the main question the study is designed to answer.
best option for cholestatoma
what operation with least recurrence
Measured: about 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start30 Jun 2023 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Oct 2025 (estimated)
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 Paediatric 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Abdo, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584891
- Sponsor's protocol ID
- mariambarkat
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alves RD, Cabral Junior F, Fonseca AC, Bento RF. Mastoid Obliteration with Autologous Bone in Mastoidectomy Canal Wall Down Surgery: a Literature Overview. Int Arch Otorhinolaryngol. 2016 Jan;20(1):76-83. doi: 10.1055/s-0035-1563382. Epub 2015 Aug 24.
PubMed 26722350
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Radical Mastoidectomy With and Without Mastoid Obliteration Operations in Pediatric Population
- ClinicalTrials.gov ID
- NCT05584891
- Acronym / sponsor ID
- mariambarkat
- Conditions
- Paediatric Cholesteatoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 18 Oct 2022 (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.
Chronic otitis media (COM) has a significant impact on health issues since prehistoric time. It is a global disease, seen in all the continents of world having different environmental and socioeconomic background. COM is characterized as a permanent abnormality of the pars tensa or flaccida, most likely a result of earlier acute otitis media, negative middle ear pressure or otitis media with effusion. COM squamous active (cholesteatoma) is a type of COM, which is a mass formed by keratinizing squamous epithelium in the middle ear and/or mastoid, subepithelial connective tissue and by the progressive accumulation of keratin debris with/without surrounding inflammatory reaction.
Detailed description
Paediatric cholesteatoma spread more extensively through the temporal bone than in adult as the temporal bone in children is well pneumatized. The disease in children is frequently more extensive and expanding, with more involvement of the peri-labyrinthine cells and petrous apex. It is a commonly encountered disease entity which requires prompt surgical management as early as possible. The management of cholesteatoma is solely surgical.
Comparatively the pediatric population has higher rates of recurrent and residual disease, possibly due to anatomic and physiologic differences. Eustachian tube anatomy and dysfunction predisposes children to more frequent infections and retraction pockets. Thus posing a greater challenge than in adults in treating cholesteatom.
The goals of surgery are to eliminate epithelial and bone disease thoroughly and prevent the recurrence, produce a dry and safe ear and to restore serviceable hearing
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: mastoidectomy and mastoid oblitrationradical mastoidectomy |
| group2 | – | Procedure: mastoidectomy and mastoid oblitrationmastoid obliteration operation. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- peadeatric population
Key inclusion criteria (2 listed)
- 1. Patient suffering from chronic suppurative otitis media, attico-antral (squamous) disease.
- 2. Age less than or equal to 18 years.
Key exclusion criteria (2 listed)
- 1. Patient having an intracranial complication of chronic suppurative otitis media.
- 2. Bony erosion of sinus plate or dural plate or bone covering the Trautmann's triangle with granulations over the erosion in patients undergoing mastoid obliteration operation.
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 |
|---|---|---|
| mastoidectomy and mastoid oblitrationForty pediatric patients with cholesteatoma indicated for radical mastoidectomy or modified radical mastoidectomies will be enrolled in our study and we will be grouped into two groups: one will undergo radical mastoidectomy alone and their operation results will be compared to other group which includes twenty pediatric patients with mastoid obliteration operation. | Procedure or surgery | group 1, group2 |
Primary outcome
best option for cholestatoma
Time frame: about 3 years
what operation with least recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Results publication: PubMed 26722350Alves RD, Cabral Junior F, Fonseca AC, Bento RF. Mastoid Obliteration with Autologous Bone in Mastoidectomy Canal Wall Down Surgery: a Literature Overview. Int Arch Otorhinolaryngol. 2016 Jan;20(1):76-83. doi: 10.1055/s-0035-1563382. Epub 2015 Aug 24.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Cholesteatoma, run by Assiut 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 2 inclusion and 2 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 18 Oct 2022. 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 Ahmed Abo Elwafa, MD (01060871584 ext. +2, mailto:ahmed.mohamed45@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best option for cholestatoma (time frame: about 3 years). 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 NCT05584891, 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 18 Oct 2022.