An observational study in Chronic Suppurative Otitis Media, Mastoid Cavity and Pneumatization, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Al-Azhar University · Observational
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.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 40 is below the median of 150 across 57 observational studies indexed under Otitis Media.
Browse Otitis Media studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 1.5 month and 3 months postoperative
Tympanometric volume
Tympanometry volume: Patients underwent tympanometry to measure the External Canal Volume in ml, which is the combined volume of external auditory canal, middle ear, and mastoid air space. Those patients underwent tympanometry of the contralateral ear (with intact Tympanic Membrane), the detected External Canal Volume was the volume of the external auditory canal only. So, we subtracted the volume of the normal ear from that of contralateral ear with the perforation to have the volume of middle ear and mastoid space of the diseased ear. For patients with bilateral perforations, the mean of ear canal volume of the normal ear from the unilateral cases was used.
Time frame: preoperative
Degree of mastoid pneumatization on CT scan temporal bone
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 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. Then the degree of mastoid pneumatization was categorized into 5 categories: 1. Grade 0: Sclerotic mastoid with limited pneumatization 2. Grade 1: Hypo-pneumatization. 3. Grade 2: Moderate pneumatization. 4. Grade 3: Good pneumatization. 5. Grade 4: Hyper-pneumatization.
Time frame: Preoperative
3D mastoid volume measurement
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. We ensured that the air cells within the targeted mastoid were fully segmented without including the surrounding bone or tissues at all levels of the Axial CT cuts. Rechecking the coronal and sagittal cuts air cells was done to be sure that all air cells of the mastoid were included 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.
Time frame: Preoperative
Ran from Nov 2022 to primary completion in Nov 2024, 24 months.
Of 22 observational studies under Otitis Media, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's 24 months is close to that.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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