Clinical trial NCT06874426: The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction
Official title: The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meningioma
Pituitary Disease
Pituitary Adenoma
Craniopharyngioma
Endoscopic Pituitary Surgery
Olfactory Dysfunction
Keywords: olfactory dysfunction
trigeminal dysfunction
endoscopic endonasal skull base surgery
pituitary surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting with an indication for endoscopic endonasal skull base surgery for lesions in the anterior skull base (the parasellar region)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for endoscopic endonasal skull base surgery

Exclusion Criteria:

* Pre-existing anosmia
* Patients has a history of previous endoscopic endonasal skull base surgery

Primary outcomes:
measure: Incidence of olfactory dysfunction
timeFrame: From enrollment to the last evaluation 6 months postoperatively
measure: Incidence of trigeminal dysfunction
timeFrame: From enrollment to the last evaluation 6 months postoperatively
measure: Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgery
timeFrame: Until the end of study (at 3 years)
Secondary outcomes:
measure: Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery
timeFrame: From enrollment to the last evaluation 6 months postoperatively
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Vlaams-Brabant
city: Frankfurt
country: Germany
facility: Max Planck Research Unit for Neurogenetics
state: Hessen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
References: