The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06874426
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universitaire Ziekenhuizen KU Leuven
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Belgium, Germany, Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

KU Leuven, Leuven, Vlaams-Brabant, Belgium

Status

Address

KU Leuven

Leuven, Vlaams-Brabant, 3000

Site Contact

Julie van Waterschoot

[email protected]

0477910294

Frankfurt, Hessen, Germany

Status

Address

Max Planck Research Unit for Neurogenetics

Frankfurt, Hessen, 69

Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands

Status

Address

Leiden University Medical Center

Leiden, Zuid-Holland, 10702

Site Contact

Maarten Kleijwegt

[email protected]

0477910294

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