Radical Mastoidectomy Versus Mastoid Oblitration in Pediatric Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2025-10-30

Brief Summary

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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.

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Detailed Description

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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

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Paediatric Cholesteatoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

radical mastoidectomy

mastoidectomy and mastoid oblitration

Intervention Type PROCEDURE

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.

group2

mastoid obliteration operation.

mastoidectomy and mastoid oblitration

Intervention Type PROCEDURE

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.

Interventions

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mastoidectomy 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes