An observational study in Meningioma, Pituitary Disease and Pituitary Adenoma, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
In this study, the research team will investigate the incidence and etiology of olfactory dysfunction following endoscopic endonasal skull base surgery, by combining clinical assessments with histomolecular analysis.
The incidence of olfactory dysfunction following endoscopic endonasal skull base surgery remains unclear in current research, and the results vary widely. Additionally, the pathophysiology of this postoperative olfactory dysfunction and the impact of this surgery on the trigeminal system has not been investigated to date. In this study, the investigators developed a state-of-the-art clinical pipeline with olfactory and trigeminal assessments, prior to and following endoscopic endonasal skull base surgery. Furthermore, the investigators will collect surgical waste tissue from the posterior septal mucosa, which is removed during this procedure to gain access to the sphenoid sinus and the (para)sellar region. By performing histomolecular analysis, the research group aims to elucidate the pathophysiology of olfactory dysfunction following this surgery.
255 studies on the registry are indexed under Meningioma; 85 are open to participants now.
This study's planned enrollment of 154 is above the median of 133 across 56 observational studies indexed under Meningioma.
Browse Meningioma studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients presenting with an indication for endoscopic endonasal skull base surgery for lesions in the anterior skull base (the parasellar region)
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Exclusion Criteria:
This intervention will be performed as part of the standard-of-care for patients scheduled for endoscopic endonasal skull base surgery for lesions in the (para)sellar region
Also known as: endoscopic pituitary surgery, anterior skull base surgery
Incidence of olfactory dysfunction
Time frame: From enrollment to the last evaluation 6 months postoperatively
Incidence of trigeminal dysfunction
Time frame: From enrollment to the last evaluation 6 months postoperatively
Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgery
Time frame: Until the end of study (at 3 years)
Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery
Parameters such as smoking history, allergies, age, gender, co-morbidities will be investigated as possible covariates
Time frame: From enrollment to the last evaluation 6 months postoperatively
Not enrolling at this site.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2028, 45 months after the start.
Of 29 observational studies under Meningioma, half reached primary completion within 106 months of starting (the median), counting those still running; a quarter within 60. This study's planned 45 months is below that.
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