Chronic Suppurative Otitis MediaNCT07806461
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
An observational study of Chronic Suppurative Otitis Media and Mastoid Cavity, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Suppurative Otitis Media, Mastoid Cavity, Pneumatization
- What is being tested?
- tympanoplasty type 1, Audiological Evaluation and HRCT scan temporal bone
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Nov 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Suppurative Otitis Media, Mastoid Cavity, Pneumatization, Tympanoplasty, Pediatric
- Being tested
- tympanoplasty type 1, Audiological Evaluation, HRCT scan temporal bone, 3D Mastoid Air Cell Volume
- Keywords
- Myringoplasty, Pediatric Tympanoplasty, Mastoid Ventilation, Middle Ear Volume, Mastoid volume, Mastoid pneumatization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tympanoplasty type 1Procedure or surgery
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 EvaluationDiagnostic 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.
HRCT scan temporal boneOther
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 VolumeOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1.5 month and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Nov 2022
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Suppurative Otitis MediaStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Mohamed Mohamed Gomaa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806461
- Sponsor's protocol ID
- 1595
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mastoid and Middle Ear Volume on Pediatric Tympanoplasty
- ClinicalTrials.gov ID
- NCT07806461
- Acronym / sponsor ID
- 1595
- Conditions
- Chronic Suppurative Otitis Media, Mastoid Cavity, Pneumatization, Tympanoplasty, Pediatric
- Keywords
- Myringoplasty, Pediatric Tympanoplasty, Mastoid Ventilation, Middle Ear Volume, Mastoid volume, Mastoid pneumatization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tympanoplasty type 1Under 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. | Procedure or surgery | – |
| Audiological EvaluationAudiological 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. | Diagnostic test | – |
| HRCT scan temporal boneRadiological 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 Volume3D 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. | Other | – |
Primary outcome
Structural success of Myringoplasy
Time frame: 1 month
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.
Functional success of Myringoplasty
Time frame: 1.5 month and 3 months postoperative
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Suppurative Otitis Media and Mastoid Cavity, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural success of Myringoplasy (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.