The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

NCT ID: NCT06874426

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-18

Study Completion Date

2029-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningioma Pituitary Disease Pituitary Adenoma Craniopharyngioma Endoscopic Pituitary Surgery Olfactory Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopic 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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

endoscopic pituitary surgery anterior skull base surgery

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Laura Van Gerven

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KU Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status RECRUITING

Max Planck Research Unit for Neurogenetics

Frankfurt am Main, Hesse, Germany

Site Status ACTIVE_NOT_RECRUITING

Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium Germany Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julie van Waterschoot

Role: CONTACT

+32477910294

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julie van Waterschoot

Role: primary

0477910294

Maarten Kleijwegt

Role: primary

0477910294

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S69823

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cryoablation of Brain Neoplasm
NCT06753617 ENROLLING_BY_INVITATION NA