Olfactory Function Following Endoscopic Endonasal Skull Base Surgery (UPSIT)

Ricardo L. Carrau, MD

Status: Unknown

Conditions: Skull Base Pathology

Treatments: Procedure: endoscopic endonasal surgery with UPSIT

Study type: Interventional

Funder types: Other

Identifiers

NCT02165969

2014H0063

Details and patient eligibility

About

The purpose of this study is to compare a subject's sense of smell before and after endoscopic endonasal surgery to remove a skull base abnormality (i.e. tumor, inflammatory process, fracture, defect, etc.) and use the information collected to validate approaches to surgery that will minimize side effects to the sense of smell function. Data will be collected using a smell identification test along with two questionnaires. In addition, demographic, medical history, treatment, outcome, and follow-up information will be collected.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with skull base pathologies requiring endonasal surgery at The Ohio State University Wexner Medical Center
• 18 years or older
• Able to consent for self
• Negative serum pregnancy test for women of childbearing potential

Exclusion criteria

• Patient unable to return to clinic at specific follow-up times
• Pregnant or nursing
• Prisoners

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

endoscopic endonasal surgery with UPSIT

Experimental group

Description:

endoscopic endonasal surgery with UPSIT prior to surgery and at months 1, 3, 6, and 12 after surgery.

Treatment:

Procedure: endoscopic endonasal surgery with UPSIT