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Radical Mastoidectomy Versus Mastoid Oblitration in Pediatric Population

Comparative Study Between Radical Mastoidectomy With and Without Mastoid Obliteration Operations in Pediatric Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05584891
Enrollment
40
Registered
2022-10-18
Start date
2023-06-30
Completion date
2025-10-30
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric Cholesteatoma

Brief 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. 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

Interventions

PROCEDUREmastoidectomy and mastoid oblitration

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
Yes

Inclusion criteria

\- 1. Patient suffering from chronic suppurative otitis media, attico-antral (squamous) disease. 2\. Age less than or equal to 18 years.

Exclusion criteria

\- 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.

Design outcomes

Primary

MeasureTime frameDescription
best option for cholestatomaabout 3 yearswhat operation with least recurrence

Countries

Egypt

Contacts

Primary ContactAhmed Abo Elwafa, MD
mailto:ahmed.mohamed45@med.aun.edu.eg01060871584
Backup ContactMohamed Alhussaini, MD
mailto:Mohamed_Alhussaini@aun.edu.eg01067485885

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026