Radical Mastoidectomy Versus Mastoid Oblitration in Pediatric Population

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Paediatric Cholesteatoma
• Intervention / Treatment: Procedure: mastoidectomy and mastoid oblitration

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Ahmed Abo Elwafa, MD; Phone Number: +2 01060871584; Email: mailto:ahmed.mohamed45@med.aun.edu.eg
• Study Contact Backup: Name: Mohamed Alhussaini, MD; Phone Number: +2 01067485885; Email: mailto:Mohamed_Alhussaini@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

peadeatric population

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; radical mastoidectomy	Procedure: 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.
group2; mastoid obliteration operation.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
best option for cholestatoma	what operation with least recurrence	about 3 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Alves RD, Cabral Junior F, Fonseca AC, Bento RF. Mastoid Obliteration with Autologous Bone in Mastoidectomy Canal Wall Down Surgery: a Literature Overview. Int Arch Otorhinolaryngol. 2016 Jan;20(1):76-83. doi: 10.1055/s-0035-1563382. Epub 2015 Aug 24.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2023
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): October 30, 2025

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Keratosis; Cholesteatoma
• Other Study ID Numbers: mariambarkat

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No