Long-Term Follow-Up After Translabyrinthine IAC Tumor Removal With Simultaneous Cochlear Implantation.
Anselm Joseph Gadenstaetter, Alice Barbara Auinger, Matthias Gerlitz...
https://pubmed.ncbi.nlm.nih.gov/39284021Actively Recruiting
Age: 18Years - 99Years
All Genders
ID03745560
Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study
Led by Christoph Arnoldner · Updated on 2024-11-25
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study patients undergoing simultaneous translabyrinthine vestibular schwannoma removal and cochlear implantation. The main goal is to understand how intraoperative electrically evoked auditory brainstem response (eABR) readings relate to hearing outcomes after surgery. The study is observational, focusing on measuring and correlating these responses without altering the standard treatment. Patients have eABR tests before surgery, before tumor removal, and after tumor removal. After surgery, cochlear implants are fitted following routine procedures. The study groups eABR responses into three categories—good, weak, or no response—and compares these with postoperative speech understanding using the Freiburger monosyllables test. Participants are monitored for two years to assess the connection between eABR results and hearing with the cochlear implant. Hearing performance is evaluated through speech tests, and the study involves no experimental treatment changes. Researchers observe and record outcomes to better understand hearing rehabilitation after vestibular schwannoma surgery combined with cochlear implantation.
CONDITIONS
Brief Title
Intraoperative EABR for Decision Making
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection
- Patients wanting hearing rehabilitation with a cochlear implant
You will not qualify if you...
- Patients who do not want to be part of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate post-operative period
Participants undergo translabyrinthine vestibular schwannoma resection surgery with intraoperative eABR measurements before and after tumor resection, followed by routine cochlear implant fitting.
1 surgical visit with intraoperative measurements
Long-term Monitoring
Duration - Up to 2 years
Participants are observed for postoperative hearing results with cochlear implant, which are correlated to intraoperative eABR results over time.
Follow-up visits as per routine cochlear implant care
Trial Site Locations
Total: 1 location
1
AKH, MUW
Vienna, Austria, Austria, 1090
Actively Recruiting
Loading map...
Research Team
V
Valerie Dahm
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here