Temporal Bone AbnormalitiesNCT06597877
CT Temporal Bone Anatomical Variations
An observational study of Temporal Bone Abnormalities, run by Assiut University.
Trial summary
This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Temporal Bone Abnormalities
- What is being tested?
- CT
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Sep 2026
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with unilateral ear pathology will be randomly assigned to do CT temporal bone, The presence of five variants was determined. These variants were: a high dehiscent jugular bulb, an anteriorly located sigmoid sinus, a deep sinus tympani, an enlarged cochlear aqueduct, and an enlarged internal auditory meatus (IAM). A GE LightSpeed 16, four-slice, helical CT scanner (Fairfield, Connecticut, USA) was used for all patients. The scan parameters were as follows: 1 mm slices, smart Ma (50-250 Ma), 120 kV, 0.8-second rotation time, 0.562:1 pitch factor, and 5.62 mm rotation speed. All scans covered an area from 1 cm inferior to the mastoid tip to 1 cm superior to the petrous temporal bone.
Who may be able to join
- All adult patients presented with any middle ear pathology indicated for temporal bone radiological evaluation and were willing to participate in the study
Who cannot join
- 1- patients with temporal bone neoplastic disorders distorting normal temporal bone anatomy.
- 2- Extensive trauma to the temporal bone 3- Patients with congenital anomalies and craniofacial disproportions 4- Patients with mastoid surgery 5- Patients in whom radiological evaluation is contraindicated
Trial locations and contacts
No sites are listed yet.
Mohamed Abdelhai Elhussieny contact
About this study
This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance
Read the detailed description
The temporal bone has a difficult anatomical structure for otologists and radiologists.In addition to its anatomical complexity, variations in the three-dimensional relationships of structures within the temporal bone need additional attention. The assessment of these relationships is of primary importance in diagnosis, treatment planning, and preoperative management. High-resolution computed tomography (CT) helps locate the anatomical structures within the temporal bone. Preoperative knowledge of the courses of vascular structures within and neighboring the temporal bone is of primary importance. If not detected preoperatively, variations in the localizations of the vascular structures may lead to disastrous consequences during surgery. The surgically important positions of the vascular structures that are generally accepted as normal variants are, High-resolution CT has made it possible for clinicians to study middle- and inner-ear pathology before undertaking surgery. This is particularly useful when the disease has altered the anatomy, resulting in complications such as a lateral canal fistula and facial canal or tegmen erosion there have been several studies reporting the value of high-resolution CT for investigations of cholesteatoma, temporal bone tumors, and congenital anomalies studies on the prevalence of normal anatomical variations of the temporal bone as the use of high-resolution CT imaging for temporal bone investigations is now widespread, it is necessary for the investigating otologist to be aware of common anatomical variations and their clinical implications
- Conditions
- Temporal Bone Abnormalities
- Being tested
- CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTRadiation
Patients with unilateral ear pathology will be randomly assigned to do CT temporal bone, The presence of five variants was determined. These variants were: a high dehiscent jugular bulb, an anteriorly located sigmoid sinus, a deep sinus tympani, an enlarged cochlear aqueduct, and an enlarged internal auditory meatus (IAM). A GE LightSpeed 16, four-slice, helical CT scanner (Fairfield, Connecticut, USA) was used for all patients. The scan parameters were as follows: 1 mm slices, smart Ma (50-250 Ma), 120 kV, 0.8-second rotation time, 0.562:1 pitch factor, and 5.62 mm rotation speed. All scans covered an area from 1 cm inferior to the mastoid tip to 1 cm superior to the petrous temporal bone.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evaluation of the anatomical variations of the Temporal bone
This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temporal Bone AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihal Samal Sayed, Assiut University
- Investigators
- Mohamed Mahmoud Roshdy, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597877
- Sponsor's protocol ID
- CT Temporal bone variations
- Status last verified
- Aug 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walshe P, McConn Walsh R, Brennan P, Walsh M. The role of computerized tomography in the preoperative assessment of chronic suppurative otitis media. Clin Otolaryngol Allied Sci. 2002 Apr;27(2):95-7. doi: 10.1046/j.1365-2273.2002.00538.x.
PubMed 11994113Visvanathan V, Morrissey MS. Anatomical variations of the temporal bone on high-resolution computed tomography imaging: how common are they? J Laryngol Otol. 2015 Jul;129(7):634-7. doi: 10.1017/S0022215115001115. Epub 2015 Jun 15.
PubMed 26072959Atilla S, Akpek S, Uslu S, Ilgit ET, Isik S. Computed tomographic evaluation of surgically significant vascular variations related with the temporal bone. Eur J Radiol. 1995 May;20(1):52-6. doi: 10.1016/0720-048x(95)00619-2.
PubMed 7556255Tatlipinar A, Tuncel A, Ogredik EA, Gokceer T, Uslu C. The role of computed tomography scanning in chronic otitis media. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):33-8. doi: 10.1007/s00405-011-1577-z. Epub 2011 Mar 24.
PubMed 21431950Jackler RK, Dillon WP, Schindler RA. Computed tomography in suppurative ear disease: a correlation of surgical and radiographic findings. Laryngoscope. 1984 Jun;94(6):746-52. doi: 10.1288/00005537-198406000-00004.
PubMed 6727511
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Temporal Bone Anatomical Variations
- ClinicalTrials.gov ID
- NCT06597877
- Acronym / sponsor ID
- CT Temporal bone variations
- Conditions
- Temporal Bone Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance
Detailed description
The temporal bone has a difficult anatomical structure for otologists and radiologists.In addition to its anatomical complexity, variations in the three-dimensional relationships of structures within the temporal bone need additional attention. The assessment of these relationships is of primary importance in diagnosis, treatment planning, and preoperative management. High-resolution computed tomography (CT) helps locate the anatomical structures within the temporal bone. Preoperative knowledge of the courses of vascular structures within and neighboring the temporal bone is of primary importance. If not detected preoperatively, variations in the localizations of the vascular structures may lead to disastrous consequences during surgery. The surgically important positions of the vascular structures that are generally accepted as normal variants are, High-resolution CT has made it possible for clinicians to study middle- and inner-ear pathology before undertaking surgery. This is particularly useful when the disease has altered the anatomy, resulting in complications such as a lateral canal fistula and facial canal or tegmen erosion there have been several studies reporting the value of high-resolution CT for investigations of cholesteatoma, temporal bone tumors, and congenital anomalies studies on the prevalence of normal anatomical variations of the temporal bone as the use of high-resolution CT imaging for temporal bone investigations is now widespread, it is necessary for the investigating otologist to be aware of common anatomical variations and their clinical implications
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with unilateral ear pathology will be randomly assigned to do CT temporal bone, The presence of five variants was determined. These variants were: a high dehiscent jugular bulb, an anteriorly located sigmoid sinus, a deep sinus tympani, an enlarged cochlear aqueduct, and an enlarged internal auditory meatus (IAM). A GE LightSpeed 16, four-slice, helical CT scanner (Fairfield, Connecticut, USA) was used for all patients. The scan parameters were as follows: 1 mm slices, smart Ma (50-250 Ma), 120 kV, 0.8-second rotation time, 0.562:1 pitch factor, and 5.62 mm rotation speed. All scans covered an area from 1 cm inferior to the mastoid tip to 1 cm superior to the petrous temporal bone.
Key inclusion criteria (1 listed)
- All adult patients presented with any middle ear pathology indicated for temporal bone radiological evaluation and were willing to participate in the study
Key exclusion criteria (2 listed)
- 1- patients with temporal bone neoplastic disorders distorting normal temporal bone anatomy.
- 2- Extensive trauma to the temporal bone 3- Patients with congenital anomalies and craniofacial disproportions 4- Patients with mastoid surgery 5- Patients in whom radiological evaluation is contraindicated
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 |
|---|---|---|
| CTPatients with unilateral ear pathology will be randomly assigned to do CT temporal bone, The presence of five variants was determined. These variants were: a high dehiscent jugular bulb, an anteriorly located sigmoid sinus, a deep sinus tympani, an enlarged cochlear aqueduct, and an enlarged internal auditory meatus (IAM). A GE LightSpeed 16, four-slice, helical CT scanner (Fairfield, Connecticut, USA) was used for all patients. The scan parameters were as follows: 1 mm slices, smart Ma (50-250 Ma), 120 kV, 0.8-second rotation time, 0.562:1 pitch factor, and 5.62 mm rotation speed. All scans covered an area from 1 cm inferior to the mastoid tip to 1 cm superior to the petrous temporal bone. | Radiation | – |
Primary outcome
Radiological evaluation of the anatomical variations of the Temporal bone
Time frame: Baseline
This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance This study aimed to identify the prevalence of normal variations of temporal bone anatomy on high-resolution CT imaging and discuss their clinical importance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 11994113Walshe P, McConn Walsh R, Brennan P, Walsh M. The role of computerized tomography in the preoperative assessment of chronic suppurative otitis media. Clin Otolaryngol Allied Sci. 2002 Apr;27(2):95-7. doi: 10.1046/j.1365-2273.2002.00538.x.
- Results publication: PubMed 26072959Visvanathan V, Morrissey MS. Anatomical variations of the temporal bone on high-resolution computed tomography imaging: how common are they? J Laryngol Otol. 2015 Jul;129(7):634-7. doi: 10.1017/S0022215115001115. Epub 2015 Jun 15.
- Results publication: PubMed 7556255Atilla S, Akpek S, Uslu S, Ilgit ET, Isik S. Computed tomographic evaluation of surgically significant vascular variations related with the temporal bone. Eur J Radiol. 1995 May;20(1):52-6. doi: 10.1016/0720-048x(95)00619-2.
- Results publication: PubMed 21431950Tatlipinar A, Tuncel A, Ogredik EA, Gokceer T, Uslu C. The role of computed tomography scanning in chronic otitis media. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):33-8. doi: 10.1007/s00405-011-1577-z. Epub 2011 Mar 24.
- Results publication: PubMed 6727511Jackler RK, Dillon WP, Schindler RA. Computed tomography in suppurative ear disease: a correlation of surgical and radiographic findings. Laryngoscope. 1984 Jun;94(6):746-52. doi: 10.1288/00005537-198406000-00004.
- Individual participant dataSharing planned: No
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.
Mohamed Abdelhai Elhussieny contact
Mohamed Mahmoud Roshdy, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Temporal Bone Abnormalities, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nihal Kamal Sayed, Resident (+2001101987694, kamalnehal87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation of the anatomical variations of the Temporal bone (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06597877, which also lists 5 linked publications.
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 19 Sep 2024.