Reconstructive Ear Surgery in Pediatrics

Not Applicable

Recruiting

• Conditions: Ossicle Chain Disarticulation
• Interventions: Other: recostructive ear surgery

• Registration Number: NCT05813990
• Lead Sponsor: Assiut University

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

Study Timeline

• Study Start: 2022-10-22
• Study First Submitted: 2023-03-19
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-14
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric patient with conductive hearing loss	recostructive ear surgery	All pediatric patients aged below 18 years old will subjected to reconstructive ear surgery (ossiculoplasty)

Primary Outcome Measures

Name	Time	Method
reconstuctive ear surgery in pediartic population	2m,6m and 1year	Evaluation 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.

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt