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Radical Mastoidectomy Versus Mastoid Oblitration in Pediatric Population

A

Assiut University

Status

Not yet enrolling

Conditions

Paediatric Cholesteatoma

Treatments

Procedure: mastoidectomy and mastoid oblitration

Study type

Observational

Funder types

Other

Identifiers

NCT05584891
mariambarkat

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

2 months to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

    1. Patient having an intracranial complication of chronic suppurative otitis media.
  1. 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 design

40 participants in 2 patient groups

group 1
Description:
radical mastoidectomy
Treatment:
Procedure: mastoidectomy and mastoid oblitration
group2
Description:
mastoid obliteration operation.
Treatment:
Procedure: mastoidectomy and mastoid oblitration

Trial contacts and locations

1

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Central trial contact

Mohamed Alhussaini, MD; Ahmed Abo Elwafa, MD

Data sourced from clinicaltrials.gov

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