Olfactory Function Following Endoscopic Endonasal Skull Base Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Skull Base Pathology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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endoscopic endonasal surgery with UPSIT

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

Group Type EXPERIMENTAL

endoscopic endonasal surgery with UPSIT

Intervention Type PROCEDURE

Interventions

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endoscopic endonasal surgery with UPSIT

Intervention Type PROCEDURE

Eligibility Criteria

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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