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NCT Number: NCT06874426

The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic endonasal skull base surgery

Procedure

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

Other names: endoscopic pituitary surgery, anterior skull base surgery

Primary outcomes

  1. Incidence of olfactory dysfunction

    Time frame: From enrollment to the last evaluation 6 months postoperatively

  2. Incidence of trigeminal dysfunction

    Time frame: From enrollment to the last evaluation 6 months postoperatively

  3. Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgery

    Time frame: Until the end of study (at 3 years)

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Julie van Waterschoot

CONTACT

[email protected]

+32477910294

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: Endo-Olfact

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 13, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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