Radiological Classification of the Facial Nerve

October 5, 2016 updated by: Imam Abdulrahman Bin Faisal University

Radiological Classification of the Vertical Segment of Facial Nerve in Cochlear Implant Surgery

Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant. Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is important to safely perform the posterior tympanotomy. Anatomical variation of facial nerve such as lateral or anterior position of vertical segment of facial nerve, will render this approach challenging. In this research, investigators proposed a Radiological Classification system of the position of vertical segment of facial nerve in relation to the lateral semicircular canal to predict difficult cases with narrow facial recess.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cochlear implantation done by mastoidectomy, posterior tympanotomy and round window membrane insertion or cochleostomy, if we have to. In cases with very laterally placed vertical segment of the facial nerve a trans- mastoid trans- attic approach used with trans canal monitoring as an alternative approach. Position of the vertical segment of the facial nerve (VFN) determined by coronal view HRCT of temporal bone, bone window of 0.6 mm thickness by using the cut posterior to the internal auditory canal at the level of lateral semicircular canal (LSCC) and then drawing a line parallel to the bony canal of the VFN and another parallel line on the outer bony wall of lateral semicircular canal (LSCC), and comparing level of both. The location of the facial nerve classified into normal if the FN is medial, same level or lateral to LSCC . Investigators referred the laterally placed FN (LPFN) when the whole vertical segment of facial nerve is lateral to LSCC. In addition, distance between VFN and LSCC was measured in cases of laterally placed FN.

Investigators proposed a radiological classification system of the mastoid segment of facial nerve to predict round window niche accessibility through posterior tympanotomy pre-operatively by using coronal view computed tomography scan of temporal bone. Facial nerve position classified into 3 types in relation to LSCC:

  1. TYPE I Medial to LSCC
  2. TYPE II Same level of LSCC
  3. TYPE III Laterally placed to LSCC III a) Less than 2mm III b) More than 2mm

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • EP
      • Al-Khobar, EP, Saudi Arabia, 31952
        • Dammam University KFHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- Patients admitted to otorhinolaryngology department at king Fahad Hospital of University

Description

Inclusion Criteria:

  • All patient who underwent cochlear implant surgery with preoperative computed tomography scan and high resolution CT scan of temporal bone

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cochlear Implant
Patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery
Other: cochlear implant surgery
patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological classification of vertical segment of facial nerve
Time Frame: 48 hours before surgery

- Radiological classification of vertical segment of facial nerve by studying temporal bone CT scan using an implemented scoring system

  1. TYPE I Medial to LSCC
  2. TYPE II Same level of LSCC
  3. TYPE III Laterally placed to LSCC III a) Less than 2mm III b) More than 2mm
48 hours before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical approach in cochlear implantation
Time Frame: For 4 hours after start of surgery
The surgical approach used for cochlear implantation
For 4 hours after start of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Investigators

  • Principal Investigator: Laila M Al Telmesani, MD, ENTDepartment, Dammam University, Dammam, Saudi Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENT_1_10_2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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