Could a simple ear test replace CT scans before pediatric ear surgery?
NCT ID NCT07806461
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This study looks at children aged 8 to 18 having surgery to repair a hole in the eardrum, a procedure called type 1 tympanoplasty. Researchers want to know if the size of the mastoid and middle ear spaces affects how well the surgery works. They will compare two graft materials, fascia and cartilage, and check whether a non-invasive test called tympanometry can predict mastoid ventilation as seen on CT scans. The goal is to see if tympanometry could reduce the need for routine CT scans before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Type 1 tympanoplasty (myringoplasty) using temporalis fascia graft or tragal cartilage
- What this could lead to
- If successful, this could help doctors predict surgical outcomes without routine CT scans, and identify the better graft material for children.
- What could go wrong
- This is a small observational study, so results may not apply broadly. Also, tympanometry may not reliably reflect mastoid ventilation in all children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
40 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pediatric patients with chronic otitis media with perforation, who were candidates for type 1 Tympanoplasty at Al Zahraa university hospital (3ry care center) outpatient clinic, otorhinolaryngology department and surgical theater.
- Ages
-
8 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with Chronic suppurative otitis media with perforation (Tubotympanic type). * Age group of patients between 8 to 18 years. * Both genders were included. * Written informed consent obtained from all patient's parents or guardians. Exclusion criteria: * All Ear Acute infections, absence of ear drainage for the last 3 months prior to surgery and absence of ossicular pathology and mastoiditis on HRCT images of the temporal bone. * Patients with ossicular chain defects, cholesteatoma, tympanosclerosis, history of previous ear surgery. * Patients with parents who refuse to participate in the study. * Patients with any uncontrolled systemic diseases
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Al Zahraa university hospital
Cairo, Abbasyia, 11517, Egypt
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Other studies related to the condition(s) this trial covers.
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