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Completed
NCT07806461
Study the Impact of the Mastoid and Middle Ear Volume on the Success of Type 1 Tympanoplasty in Pediatric Age, With Comparing Using Cartilage and Fascial Grafts Through This, Strength the Hypothesis of That Total Tympanometry Volume Correlates With Ventilated Mastoid Air Cells Volume on CT Scans
Conditions: Chronic Suppurative Otitis Media, Mastoid Cavity, Pneumatization, Tympanoplasty, Pediatric
Sex: All
Ages: 8 Years – 18 Years
Healthy volunteers: No
Enrollment: 40
Sponsor: Al-Azhar University
Location: Al Zahraa university hospital Cairo Abbasyia
Summary
The goal of this observational study is to know the impact of the mastoid and middle ear volume on the success of type 1 tympanoplasty in pediatric age, with a closer view on the comparison of using cartilage and fascial grafts through this.
The investigators also hoping to strength the hypothesis of that total tympanometry volume correlates with ventilated mastoid air cells on Computed Topography (CT) scans that allow us to predict a well-ventilated mastoid air cell system.
This may help reduce the need for pre-operative CT scans in uncomplicated cases with tympanic membrane perforations.
The main question it aims to answer is:
Does Mastoid ventilation affect the success of tympanoplasty (Type 1) in pediatric age group? and which graft is better and if the tympanometry volume (non invasive investigation) correlate with the degree of the mastoid pneumatization degree and volume (based on CT scan and 3D volumetric measuring).
Participants already taking intervention a as part of their regular surgical treatment of chronic suppurative otitis media with perforation in the form of Type 1 tympanoplasty (Myringoplasty), informed consent was obtained from all the study participants guardians.
Regular postoperative follow up of the success rate (structural success was evaluated 1 month postoperatively) and functional success were evaluated at 1.5 months and 3 months postoperatively.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07806461). StuddyBuddy aggregates publicly available trial information.