The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

Recruiting

• Conditions: Pituitary Disease; Pituitary Adenoma; Craniopharyngioma; Endoscopic Pituitary Surgery; Olfactory Dysfunction; Meningioma

• Registration Number: NCT06874426
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-13
• Study Start: 2025-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2028-12
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of olfactory dysfunction	From enrollment to the last evaluation 6 months postoperatively
Incidence of trigeminal dysfunction	From enrollment to the last evaluation 6 months postoperatively
Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgery	Until the end of study (at 3 years)

Secondary Outcome Measures

Name	Time	Method
Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery	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

Trial Locations

Locations (3)

KU Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Max Planck Research Unit for Neurogenetics; 🇩🇪 Frankfurt, Hessen, Germany

Leiden University Medical Center; 🇳🇱 Leiden, Zuid-Holland, Netherlands