Reconstructive Ear Surgery in Pediatrics

NCT ID: NCT05813990

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-22

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ossicle Chain Disarticulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric patient with conductive hearing loss

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

Group Type OTHER

recostructive ear surgery

Intervention Type OTHER

recostructive ear surgery in pediatric population

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

recostructive ear surgery

recostructive ear surgery in pediatric population

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ossiculoplasty

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

zeinab salah eldin mohamed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

zeinab salah eldin mohamed, MD

Role: CONTACT

01065475006

mohamed abd elhay alhusaini, lecturer

Role: CONTACT

01067485885

References

Explore related publications, articles, or registry entries linked to this study.

Kamrava B, Roehm PC. Systematic Review of Ossicular Chain Anatomy: Strategic Planning for Development of Novel Middle Ear Prostheses. Otolaryngol Head Neck Surg. 2017 Aug;157(2):190-200. doi: 10.1177/0194599817701717. Epub 2017 May 2.

Reference Type BACKGROUND
PMID: 28463590 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ossiculoplasty in pediatrics

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

AuriNovo for Auricular Reconstruction
NCT04399239 TERMINATED PHASE1/PHASE2