An observational study in Severe to Profound Sensorineural Hearing Loss and Undergoing Cochlear Implant Surgery, sponsored by Imam Abdulrahman Bin Faisal University. Completed at 1 site in Saudi Arabia. Open to participants aged 1 Year to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-06.
Sponsored by Imam Abdulrahman Bin Faisal University · Observational
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.
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:
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 140 is above the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Imam Abdulrahman Bin Faisal University is the lead sponsor of 88 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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
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 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
Time frame: 48 hours before surgery
Surgical approach in cochlear implantation
The surgical approach used for cochlear implantation
Time frame: For 4 hours after start of surgery
Plan to share: Undecided
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Imam Abdulrahman Bin Faisal University