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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

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Official title: Impact of Mastoid and Middle Ear Volume on Pediatric Tympanoplasty

Key Details

Gender

All

Age Range

8 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2022-11-01

Completion Date

2024-11-01

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

PROCEDURE

tympanoplasty type 1

Under general anesthesia, and before the surgical intervention, the Middle Ear (ME) was examined. Conventional middle ear surgery is performed in the form of myringoplasty using temporalis fascia graft in half of the operated patients (20 patients) and using tragal cartilage in the other half (20 patients). Myringoplasty was done by microscopic or endoscopic method using 4 mm or 2.7 mm, 18 cm, 0-degree diameter rigid endoscope (Karl Storz; Germany). Different techniques were used including endaural approach and trans canal approach.

DIAGNOSTIC_TEST

Audiological Evaluation

Audiological Evaluation in the form of preoperative pure tone audiometry, tympanometry and Eustachian Tube Function (ETF) (Inflation-Deflation test) either good or bad ETF with recording of the External Canal Volume(ECV) (Total Tympanometry volume) in ml. The bone conduction, air conduction, and air bone gap (ABG) values were recorded. The results of pure tone audiometry were calculated at four frequencies (500, 1,000, 2,000 and 3,000 Hz) to categories hearing loss into minimal, mild, moderate or severe hearing loss.

OTHER

HRCT scan temporal bone

Radiological Evaluation in the form of preoperative Temporal bone High Resolution CT (HRCT) scans were performed on all patients to exclude ME pathologies and ossicular chain defects to achieve the inclusion and exclusion criteria and for evaluation and further calculation of ME cavity and mastoid cavity volume in Cm3. The Degree of mastoid pneumatization was done using the method proposed by Aladeyelu et al. 2023 which depend on a fixed landmark which was the sigmoid sinus at the level of the Lateral Semi Circular Canal (LSCC) on the axial CT images on which the lateral convex or semicircular-shaped line/border of the sigmoid sinus was divided into three equal segments by two imaginary dots: superior-lateral 1/3, lateral 1/3, and inferolateral 1/3.

OTHER

3D Mastoid Air Cell Volume

3D Mastoid Air Cell Volume was measured as follows: HRCT images were taken in the axial plane at 1-mm intervals without intravenous contrast material administration. Coronal and sagittal Multiplanar Reformation (MPR) images were constructed. The obtained image information, stored as a DICOM (digital imaging and communication in medicine) file, was transferred to a personal computer and a 3D image was reconstructed with a software program using a multiplanar volume-rendering method then we created an automatic segment generator by using the threshold method. Subtraction of the external auditory canal and petrous apex was done using the digital subtraction technique to have only the volume of the ME and mastoid air cells, the volume was measured then in cm3.

Locations (1)

Al Zahraa university hospital

Cairo, Abbasyia, Egypt