Actively Recruiting
The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-04-23
154
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how often and why problems with smell occur after patients undergo endoscopic endonasal skull base surgery. This surgery is used to treat conditions affecting the area around the pituitary gland and other nearby regions. The study aims to understand how this surgery affects the sense of smell and the trigeminal nerve system, which has not been studied before. The study involves detailed assessments of participants' smell and trigeminal function before and after the surgery. Researchers will also collect tissue removed during surgery from the posterior septal mucosa to analyze it at a molecular level. This analysis aims to uncover the biological reasons behind smell and trigeminal dysfunction after the procedure. Participants will be evaluated from the time they enroll until six months after surgery, with follow-up extending up to three years to study the causes of dysfunction. The study measures include the frequency of smell and trigeminal problems and the risk factors contributing to these issues. Participants will undergo clinical assessments and tissue analysis to help researchers understand these effects thoroughly.
CONDITIONS
Brief Title
The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients scheduled for endoscopic endonasal skull base surgery
You will not qualify if you...
- Pre-existing anosmia
- History of previous endoscopic endonasal skull base surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate recovery period
Participants undergo endoscopic endonasal skull base surgery as part of their standard care, with assessments of olfactory and trigeminal function before and immediately after surgery.
1 surgery visit and immediate post-operative assessments
Duration - Up to 6 months postoperatively
Participants are monitored for olfactory and trigeminal function to evaluate dysfunction and recovery over time following surgery.
Multiple evaluations during follow-up visits up to 6 months
Trial Site Locations
Total: 3 locations
1
KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
2
Max Planck Research Unit for Neurogenetics
Frankfurt am Main, Hesse, Germany, 69
Active, Not Recruiting
3
Leiden University Medical Center
Leiden, South Holland, Netherlands, 10702
Not Yet Recruiting
Research Team
J
Julie van Waterschoot
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
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