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Clinical Trials/NCT05584891
NCT05584891
Not yet recruiting
Not Applicable

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

Assiut University1 site in 1 country40 target enrollmentJune 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Paediatric Cholesteatoma
Sponsor
Assiut University
Enrollment
40
Locations
1
Primary Endpoint
best option for cholestatoma
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 30, 2023
End Date
October 30, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Abdo

principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patient having an intracranial complication of chronic suppurative otitis media.
  • 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.

Outcomes

Primary Outcomes

best option for cholestatoma

Time Frame: about 3 years

what operation with least recurrence

Study Sites (1)

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