NCT06597877

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Oct 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2024Sep 2026

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

September 12, 2024

Last Update Submit

September 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Interventions

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.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- All adult patients presented with any middle ear pathology indicated for temporal bone radiological evaluation and were willing to participate in the study

You may not qualify if:

  • \- 1- patients with temporal bone neoplastic disorders distorting normal temporal bone anatomy.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 11994113BACKGROUND
  • Visvanathan 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.

    PMID: 26072959BACKGROUND
  • Atilla 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.

    PMID: 7556255BACKGROUND
  • Tatlipinar 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.

    PMID: 21431950BACKGROUND
  • Jackler 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.

    PMID: 6727511BACKGROUND

Study Officials

  • Mohamed Mahmoud Roshdy, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Nihal Kamal Sayed, Resident

CONTACT

Mohamed Abdelhai Elhussieny

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nehal Kamal Sayed

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share