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Reconstructive Ear Surgery in Pediatrics

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05813990
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
25.3
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: recostructive ear surgery
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reconstructive Ear Surgery in Pediatric Population. Cross Sectional Study
Actual Study Start Date :
Oct 22, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Pediatric patient with conductive hearing loss

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

Other: recostructive ear surgery
recostructive ear surgery in pediatric population
Other Names:
  • ossiculoplasty

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    zeinab salah eldin mohamed, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05813990
    Other Study ID Numbers:
    • ossiculoplasty in pediatrics
    First Posted:
    Apr 14, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 18, 2023