Severe to Profound Sensorineural Hearing LossNCT02925208
Radiological Classification of the Facial Nerve
An observational study of Severe to Profound Sensorineural Hearing Loss and Undergoing Cochlear Implant Surgery, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Severe to Profound Sensorineural Hearing Loss, Undergoing Cochlear Implant Surgery
- What is being tested?
- cochlear implant surgery
- How many people
- 140 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2010to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - Patients admitted to otorhinolaryngology department at king Fahad Hospital of University
Who may be able to join
- All patient who underwent cochlear implant surgery with preoperative computed tomography scan and high resolution CT scan of temporal bone
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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
- Being tested
- cochlear implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implant surgeryOther
patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant | Patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery Receives: Other: cochlear implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours before surgery
Secondary outcomes (1)
Surgical approach in cochlear implantation
The surgical approach used for cochlear implantation
Measured: For 4 hours after start of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJan 2010
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe to Profound Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laila M Al Telmesani, MD, Principal investigator, ENTDepartment, Dammam University, Dammam, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925208
- Sponsor's protocol ID
- ENT_1_10_2016
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Classification of the Vertical Segment of Facial Nerve in Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT02925208
- Acronym / sponsor ID
- ENT_1_10_2016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant | – | Other: cochlear implant surgeryPatients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Patients admitted to otorhinolaryngology department at king Fahad Hospital of University
Key inclusion criteria (1 listed)
- All patient who underwent cochlear implant surgery with preoperative computed tomography scan and high resolution CT scan of temporal bone
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cochlear implant surgerypatients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery | Other | Cochlear Implant |
Primary outcome
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
1 secondary outcome
Surgical approach in cochlear implantation
Time frame: For 4 hours after start of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila M Al Telmesani, MD principal investigator
ENTDepartment, Dammam University, Dammam, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe to Profound Sensorineural Hearing Loss and Undergoing Cochlear Implant Surgery, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological classification of vertical segment of facial nerve (time frame: 48 hours before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.