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

Impact of Mastoid and Middle Ear Volume on Pediatric Tympanoplasty

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.

This study is a combined prospective randomized clinical with a prognostic study without control group. Carried out at the Otorhinolaryngology department, AL Zahraa University Hospital, AL Azhar University for Girls - Cairo, Starting at November 2022.

The study included 40 pediatric participants (patients) with chronic otitis media with perforation, who were candidates for type 1 Tympanoplasty.

The study was approved by the Clinical Research Ethics Committee of the Faculty of Medicine for Girls, Al Azhar University; ID 1595.

All participants (patients) were subjected to the following:

Full history taking. Full Otorhinolaryngological, head and neck examination. All routine investigation. Preoperative Pure tone Audiometric, Tympanometric and Eustachian tube function evaluation with recording of the External Canal Volume (Total Tympanometry volume) in ml.

The bone conduction (BC), air conduction (AC), 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).

Preoperative Temporal bone High Resolution Computed Topography (HRCT) scans were performed on all participants (patients) to exclude middle ear pathologies and ossicular chain defects and to determine the presence of soft tissue in the antrum requiring mastoidectomy to achieve the inclusion and exclusion criteria and for calculation of middle ear cavity and mastoid cavity volume in Cm3.

All the images were evaluated by a specialist radiologist. 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.

Total volume of the tympanometry was recorded for comparison to the CT scan volumetry of the ventilated external ear canal, middle-ear space and mastoid air cells.

Operative details. Under general anesthesia, and before the surgical intervention, the middle ear was examined. Conventional middle ear surgery is performed in the form of Type 1 Tympanoplasty using Temporalis fascia graft in half of the operated participants (patients) and using Tragal cartilage in the other half.

Anatomical success was defined as an intact graft without perforation, lateralization, and a dry ear. The anatomical success (Structural) of tympanoplasty was evaluated at the postoperative One month interval.

Postoperative pure tone audiometry was evaluated at the postoperative one and half month and 3 months interval.

Functional success was defined through comparing the preoperative and postoperative pure tone audiometry tests of the participants (patients), The changes between the preoperative and postoperative ABG values were evaluated. An ABG value of 20 dB HL or less was considered to indicate functional success.

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