Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03469427
Other study ID # RCTFPTBT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date February 1, 2020

Study information

Verified date July 2018
Source Assiut University
Contact Mahmoud Mohamed Ragheb, Professor
Phone 00201003317723
Email Mmraghib@aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date February 1, 2020
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Locations

Country Name City State
Egypt Assiut university hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography Evaluation the reliability of multislice computed tomography in the assessment of facial nerve paralysis due to temporal bone trauma up to 2 years