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Multislice Computed Tomography in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma

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ClinicalTrials.gov Identifier: NCT03469427
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Sally S Hanna, Assiut University

Brief Summary:

Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures.

The onset of paralysis may be immediate, delayed or undetermined, the latter of which often occurs in unconscious patients with accompanying life-threatening complications.About one fourth has complete paralysis.


Condition or disease
Facial Nerve Paralysis

Detailed Description:

Facial nerve paralysis might have variable etiologies apart from idiopathic Bell's palsy, Congenital, infectious, inflammatory, neoplastic, neurological, toxic, iatrogenic and atraumatic causes.

Surgical intervention is indicated if 90-95% loss of function is seen at the very early period on Electroneuronography or if there is axonal degeneration on Electromyography lately with no sign of recovery.

High-resolution multislice computed tomography of the temporal bone is routinely required for evaluation of traumatic facial paralysis. High-resolution multislice computed tomography is known to be the best method for evaluating the intratemporal course of the facial nerve, but it has some limitations as well. Occasionally, the surgeon may encounter facial nerve injuries which have not been revealed in the preoperative computed tomography.

There are limited data in recent medical publications evaluating the diagnostic value of temporal bone High-resolution multislice computed tomography in the evaluation of traumatic facial paralysis. Therefore, in this study,the investigators will compare the findings of preoperative high-resolution multislice computed tomography with surgical findings to determine the diagnostic value of computed tomography.


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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reliability of Multislice Computed Tomography Scan in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography [ Time Frame: up to 2 years ]
    Evaluation the reliability of multislice computed tomography in the assessment of facial nerve paralysis due to temporal bone trauma



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of different age groups presented with facial nerve paralysis due to temporal bone trauma
Criteria

Inclusion Criteria:

  • All patients with temporal bone fracture presented with facial nerve paralysis of immediate onset and meet the criteria of facial nerve exploration regardless of age and sex.

Exclusion Criteria:

  • Pregnant women.
  • Unfit patients for surgery.
  • Patients refuse surgical intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469427


Contacts
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Contact: Mahmoud Mohamed Ragheb, Professor 00201003317723 Mmraghib@aun.edu.eg
Contact: Mohamed Hosam Eldeen Shokry, Fellow 00201005685075 hosam4hoss@yahoo.com

Locations
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Egypt
Assiut university hospital Recruiting
Assiut, Egypt
Contact: Sally Hanna, Bachelor       Romleletot15@gmail.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Sally S Hanna, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03469427     History of Changes
Other Study ID Numbers: RCTFPTBT
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Facies
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases