NCT03469427

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

March 12, 2018

Last Update Submit

July 4, 2018

Conditions

Facial Nerve Paralysis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

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

Patients of different age groups presented with facial nerve paralysis due to temporal bone trauma

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Central Study Contacts

Mahmoud Mohamed Ragheb, Professor

CONTACT

00201003317723Mmraghib@aun.edu.eg

Mohamed Hosam Eldeen Shokry, Fellow

CONTACT

00201005685075hosam4hoss@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 19, 2018

Study Start

May 1, 2018

Primary Completion

November 1, 2019

Study Completion

February 1, 2020

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

EG(1)