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The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

ConditionsMeningiomaPituitary DiseasePituitary AdenomaCraniopharyngiomaEndoscopic Pituitary SurgeryOlfactory Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients scheduled for endoscopic endonasal skull base surgery

Disqualifiers

Pre-existing anosmia

Patients has a history of previous endoscopic endonasal skull base surgery

Trial population

All patients presenting with an indication for endoscopic endonasal skull base surgery for lesions in the anterior skull base (the parasellar region)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic endonasal skull base surgery

    Procedure/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

Treatment groups

No treatment groups listed

Trial outcomes

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

Parameters such as smoking history, allergies, age, gender, co-morbidities will be investigated as possible covariates

Time frame
From enrollment to the last evaluation 6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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