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

NCT07806461 | Completed DMC

• 1 other identifier: 1595
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Suppurative Otitis Media; Mastoid Cavity; Pneumatization; Tympanoplasty; Pediatric

Keywords

Myringoplasty; Pediatric Tympanoplasty; Mastoid Ventilation; Middle Ear Volume; Mastoid volume; Mastoid pneumatization

Outcome Measures

Primary Outcomes (2)

• Structural success of Myringoplasy

  Postoperative Structural success was defined as an intact graft without perforation, lateralization, and a dry ear. The structural success of myringoplasty was evaluated at the postoperative One-month interval.

  1 month

• Functional success of Myringoplasty

  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 patients, The changes between the preoperative and postoperative Air Bone Gap (ABG) values were evaluated. An ABG value of 20 dB Hearing Loss (HL) or less was considered to indicate functional success.

  1.5 month and 3 months postoperative

Other Outcomes (3)

• Tympanometric volume

  preoperative

• Degree of mastoid pneumatization on CT scan temporal bone

  Preoperative

• 3D mastoid volume measurement

  Preoperative

Interventions

tympanoplasty type 1 PROCEDURE

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.

3D Mastoid Air Cell Volume OTHER

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.

HRCT scan temporal bone OTHER

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.

Audiological Evaluation DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Zahraa university hospital

Cairo, Abbasyia, 11517, Egypt

Location

MeSH Terms

Interventions

Myringoplasty

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Al Zahraa Hospital - Al Azhar University for Girls

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 8, 2026
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

EG (1)