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Radiological Classification of the Facial Nerve

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ClinicalTrials.gov Identifier: NCT02925208
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Dammam University

Brief Summary:
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.

Condition or disease Intervention/treatment
Severe to Profound Sensorineural Hearing Loss Undergoing Cochlear Implant Surgery Other: cochlear implant surgery

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
Actual Enrollment : 140 participants
Time Perspective: Retrospective
Official Title: Radiological Classification of the Vertical Segment of Facial Nerve in Cochlear Implant Surgery
Study Start Date : January 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Surgical approach in cochlear implantation [ Time Frame: For 4 hours after start of surgery ]
    The surgical approach used for cochlear implantation



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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- Patients admitted to otorhinolaryngology department at king Fahad Hospital of University
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


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): NCT02925208


Locations
Saudi Arabia
Dammam University KFHU
Al-Khobar, EP, Saudi Arabia, 31952
Sponsors and Collaborators
Dammam University
Investigators
Principal Investigator: Laila M Al Telmesani, MD ENTDepartment, Dammam University, Dammam, Saudi Arabia

Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT02925208     History of Changes
Other Study ID Numbers: ENT_1_10_2016
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms