Clinical trial NCT05584891: Radical Mastoidectomy Versus Mastoid Oblitration in Pediatric Population
Official title: Comparative Study Between Radical Mastoidectomy With and Without Mastoid Obliteration Operations in Pediatric Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Paediatric Cholesteatoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: peadeatric population

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

Eligibility criteria: 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.

Primary outcomes:
measure: best option for cholestatoma
timeFrame: about 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
citation: 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.