NCT02925208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

6.7 years

First QC Date

October 4, 2016

Last Update Submit

October 5, 2016

Conditions

Severe to Profound Sensorineural Hearing LossUndergoing Cochlear Implant Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    48 hours before surgery

Secondary Outcomes (1)

  • Surgical approach in cochlear implantation

    For 4 hours after start of surgery

Study Arms (1)

Cochlear Implant

Patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery

Other: cochlear implant surgery

Interventions

cochlear implant surgeryOTHER

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

Cochlear Implant

Eligibility Criteria

Age1 Year - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dammam University KFHU

Khobar, EP, 31952, Saudi Arabia

Location

Study Officials

  • Laila M Al Telmesani, MD

    ENTDepartment, Dammam University, Dammam, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

January 1, 2010

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations

SA(1)