Radical Mastoidectomy Versus Mastoid Oblitration in Pediatric Population

Not yet recruiting

• Conditions: Paediatric Cholesteatoma
• Interventions: Procedure: mastoidectomy and mastoid oblitration

• Registration Number: NCT05584891
• Lead Sponsor: Assiut University

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

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18
• Study Start: 2023-06-30
• Primary Completion: 2024-08-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	mastoidectomy and mastoid oblitration	radical mastoidectomy
group2	mastoidectomy and mastoid oblitration	mastoid obliteration operation.

Primary Outcome Measures

Name	Time	Method
best option for cholestatoma	about 3 years	what operation with least recurrence

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt