Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

Not Applicable

Completed

• Conditions: Vestibular Schwannoma; Cochlear Implantation
• Interventions: Device: Cochlear implant

• Registration Number: NCT03958006
• Lead Sponsor: Ascension South East Michigan

Brief Summary

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

Detailed Description

This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.

Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cochlear implantation	Cochlear implant	Simultaneous cochlear implantation with tumor resection

Primary Outcome Measures

Name	Time	Method
Measurement of Hearing Parameters	1 month, 3 months and 6 months postoperatively.	Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.

Secondary Outcome Measures

Name	Time	Method
Measurement of Change of Physical Symptoms Associated with Hearing Loss	1, 3 and 6 months postoperatively	Patients will complete the Dizziness Handicap Inventory
Assessment of Change of Physical Symptoms Associated with Hearing Loss	1, 3 and 6 months postoperatively	Patients will complete the Tinnitus Handicap Inventory
Assessment of incision site healing	1 week, and 1 and 3 months postoperatively	Surgeon evaluates wound hearing over 3 months

Trial Locations

Locations (1)

Seilesh Babu; 🇺🇸 Farmington Hills, Michigan, United States