The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic endonasal skull base surgery.
- Who it may be relevant to
- Registry conditions: Meningioma, Pituitary Disease, Pituitary Adenoma, Craniopharyngioma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Germany, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure 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
Primary outcome measures
- Incidence of olfactory dysfunction [Time frame: From enrollment to the last evaluation 6 months postoperatively]
- Incidence of trigeminal dysfunction [Time frame: 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)]
Secondary outcome measures (1)
- Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery [Time frame: From enrollment to the last evaluation 6 months postoperatively]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Belgium · 1 center
- KU Leuven — Leuven
Germany · 1 center
- Max Planck Research Unit for Neurogenetics — Frankfurt am Main
Netherlands · 1 center
- Leiden University Medical Center — Leiden
Identifiers
NCT: NCT06874426 · S69823