The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction (Endo-Olfact)

April 17, 2025 updated by: Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • KU Leuven
        • Contact:
        • Contact:
          • Julie van Waterschoot
        • Contact:
          • Laura Van Gerven, Professor
  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 69
        • Active, not recruiting
        • Max Planck Research Unit for Neurogenetics
  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 10702
        • Not yet recruiting
        • Leiden University Medical Center
        • Contact:
        • Contact:
          • Maarten Kleijwegt
        • Contact:
          • Marco Verstegen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of olfactory dysfunction
Time Frame: From enrollment to the last evaluation 6 months postoperatively
From enrollment to the last evaluation 6 months postoperatively
Incidence of trigeminal dysfunction
Time Frame: From enrollment to the last evaluation 6 months postoperatively
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)
Until the end of study (at 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery
Time Frame: From enrollment to the last evaluation 6 months postoperatively
Parameters such as smoking history, allergies, age, gender, co-morbidities will be investigated as possible covariates
From enrollment to the last evaluation 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S69823

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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