Olfactory Function Following Endoscopic Endonasal Skull Base Surgery

Not Applicable

• Conditions: Skull Base Pathology
• Interventions: Procedure: endoscopic endonasal surgery with UPSIT

• Registration Number: NCT02165969
• Lead Sponsor: Ricardo L. Carrau, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-23
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-18
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04
• Primary Completion: 2017-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients with decreased olfactory function after endoscopic endonasal surgery	up to 12 months post surgery	The subject will complete 2 questionnaires and the University of Pennsylvania Smell Identification Test (UPSIT) at baseline (pre-surgery) and at 1, 3, 6, and 12, months post surgery to determine if the sense of smell has been altered from surgery.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States