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Clinical Trials/NCT05813990
NCT05813990
Recruiting
N/A

Reconstructive Ear Surgery in Pediatric Population. Cross Sectional Study

Assiut University1 site in 1 country30 target enrollmentOctober 22, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Ossicle Chain Disarticulation
Sponsor
Assiut University
Enrollment
30
Locations
1
Primary Endpoint
reconstuctive ear surgery in pediartic population
Status
Recruiting
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 22, 2022
End Date
December 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

zeinab salah eldin mohamed

principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

reconstuctive ear surgery in pediartic population

Time Frame: 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.

Study Sites (1)

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