Surgical-Clinical Correlation in Unilateral Conductive Hearing Loss With Intact Tympanic Membrane

NCT07431125 | Recruiting

• 1 other identifier: MSCAZASTENT020752792026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Unilateral conductive hearing loss (UCHL) in the presence of an intact tympanic membrane represents a diagnostic challenge in otologic practice. In the absence of middle ear effusion or tympanic membrane pathology, stapes fixation secondary to otosclerosis is often considered the most probable diagnosis. However, although otosclerosis is traditionally regarded as a bilateral disease, clinical presentation may be unilateral due to asymmetric disease progression or subclinical contralateral involvement. Other etiologies, including congenital ossicular anomalies, ossicular discontinuity, tympanosclerosis without tympanic membrane involvement, or oval window abnormalities, may mimic otosclerosis both clinically and audiologically. Consequently, exploratory tympanotomy remains the gold standard for definitive diagnosis, allowing direct assessment of ossicular chain mobility and confirmation of stapes fixation. Correlating preoperative clinical suspicion with intraoperative findings is therefore essential to better define the true causes of unilateral conductive hearing loss with an intact tympanic membrane.

Conditions

Conductive Hearing Loss, Unilateral

Keywords

Otoscelrosis; Exploration Tympanotomy; stapedectomy; tympanic membrane; conductive hearing loss

Outcome Measures

Primary Outcomes (1)

• Improvement of the Airborne ( conductive ) gap

  Difference between preoperative and postoperative Average Airbone gap in dicebel

  up to three months Surgery

Study Arms (1)

Patients presented with unilatral conductive hearing loss with intact tympanic memebrane

OTHER

Patients who presented with unilateral conductive hearing loss with intact tympanic membrane will undergo exploration tympanoplasty to diagnose underlying causes and correct them surgically if possible

Procedure: Exporlation Tympanotomy

Interventions

Exporlation Tympanotomy PROCEDURE

exploration tympanotomy of the middle ear and ossicles to diagnose or detect actual causes of conductive hearing loss and correct it according to the cause

Patients presented with unilatral conductive hearing loss with intact tympanic memebrane

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral conductive hearing loss or mixed HL with intact Tympanic Membrane

You may not qualify if:

• Sensorineural hearing loss
• Chronic otitis media
• TM perforation
• Previous ear surgery

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar university Hopital in Assiut

Asyut, Asyut Governorate, 17511, Egypt

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

tarek Mansour, head of research committe

CONTACT

+0201006237731; ethicscommitt0ee@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor of otorhinolarngolgoy

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: January 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)