Radiological Classification of the Facial Nerve

Severe to Profound Sensorineural Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925208
• Other study ID #: ENT_1_10_2016
• Status: Completed
• Phase: N/A
• First received: October 4, 2016
• Last updated: October 5, 2016
• Start date: January 2010
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Dammam University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Higher Education
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Severe to Profound Sensorineural Hearing Loss
• Undergoing Cochlear Implant Surgery

Intervention

Other:
• cochlear implant surgery
patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery

Locations

Country	Name	City	State
Saudi Arabia	Dammam University KFHU	Al-Khobar	EP

Sponsors (1)

Lead Sponsor	Collaborator
Dammam University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological classification of vertical segment of facial nerve	- Radiological classification of vertical segment of facial nerve by studying temporal bone CT scan using an implemented scoring system; TYPE I Medial to LSCC; TYPE II Same level of LSCC; TYPE III Laterally placed to LSCC III a) Less than 2mm III b) More than 2mm	48 hours before surgery	Yes
Secondary	Surgical approach in cochlear implantation	The surgical approach used for cochlear implantation	For 4 hours after start of surgery	Yes