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Reconstructive Ear Surgery in Pediatrics

Reconstructive Ear Surgery in Pediatric Population. Cross Sectional Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05813990
Enrollment
30
Registered
2023-04-14
Start date
2022-10-22
Completion date
2024-12-31
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ossicle Chain Disarticulation

Brief summary

The aim of the study is 1. Evaluation of preoperative degree of hearing loss in pediatric population. 2. Evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma. 3. Assessment of best candidates for hearing restoration surgeries. 4. Comparing different surgical techniques for hearing restoration in various ossicular disorders . 5. Evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population.

Detailed description

Conductive hearing loss (CHL) results from impaired transmission of sound from the external auditory canal across the middle ear structures to the cochlea of the inner ear. A variety of disorders can affect the sound transmission pathway at the level of the ear canal, tympanic membrane, and ossicles prior to reaching the hearing organ. Ossiculoplasty is the surgical restoration of the sound transmitting mechanism of the middle ear. Ossiculoplasty has been performed as early as the 1950s.A myriad of prosthetics and surgical techniques have been described over the last half-century, with no overall consensus on the ideal method of treatment. Pediatric population are commonly known to develop conductive hearing loss secondary to various conditions such as chronic otitis media, otitis media with effusion, atelectatic otitis media and head trauma. Various methods have been fashioned to restore hearing in such patients however no consensus to the most optimum method for hearing restoration has been well established

Interventions

OTHERrecostructive ear surgery

recostructive ear surgery in pediatric population

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. patients aged ≤ 18years with CHL. 2. patients who are candidate for ossiculoplasty as surgical treatment for them.

Exclusion criteria

1. Patients with preoperative sensory neural hearing loss (SNHL). 2. Patient with intra operative complications. 3. Patients with intracranial and intratemporal complications. 4. Patients with stapes foot plate fixation, broken graft and missed patients. 5. Patients \>18years. 6. Patients who unfit for surgery.

Design outcomes

Primary

MeasureTime frameDescription
reconstuctive ear surgery in pediartic population2m,6m and 1yearEvaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population using audiometry 2 months, 6month and 1 year after surgery to assess hearing results and prosthesis stability.

Countries

Egypt

Contacts

Primary Contactzeinab salah eldin mohamed, MD
zeinab.sal2020@gmail.com01065475006
Backup Contactmohamed abd elhay alhusaini, lecturer
Mohamd_Alhussaini@aun.edu.eg01067485885

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026