Reconstructive Ear Surgery in Pediatrics

Assiut University

Status: Enrolling

Conditions: Ossicle Chain Disarticulation

Treatments: Other: recostructive ear surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05813990

ossiculoplasty in pediatrics

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Pediatric patient with conductive hearing loss

Other group

Description:

All pediatric patients aged below 18 years old will subjected to reconstructive ear surgery (ossiculoplasty)

Treatment:

Other: recostructive ear surgery