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The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06874426
Acronym
Endo-Olfact
Enrollment
154
Registered
2025-03-13
Start date
2025-03-18
Completion date
2029-09-30
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniopharyngioma, Endoscopic Pituitary Surgery, Meningioma, Olfactory Dysfunction, Pituitary Adenoma, Pituitary Disease

Keywords

olfactory dysfunction, trigeminal dysfunction, endoscopic endonasal skull base surgery, pituitary surgery

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.

Interventions

PROCEDUREEndoscopic endonasal skull base surgery

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

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of olfactory dysfunctionFrom enrollment to the last evaluation 6 months postoperatively
Incidence of trigeminal dysfunctionFrom enrollment to the last evaluation 6 months postoperatively
Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgeryUntil the end of study (at 3 years)

Secondary

MeasureTime frameDescription
Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgeryFrom enrollment to the last evaluation 6 months postoperativelyParameters such as smoking history, allergies, age, gender, co-morbidities will be investigated as possible covariates

Countries

Belgium, Germany, Netherlands

Contacts

Primary ContactJulie van Waterschoot
julie.vanwaterschoot@kuleuven.be+32477910294

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026