Olfactory Function Following Endoscopic Endonasal Skull Base Surgery (UPSIT)

March 31, 2017 updated by: Ricardo L. Carrau, MD

Olfactory Function Following Endoscopic Endonasal Skull Base Surgery: Clinical and Histological Outcomes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Ricardo Carrau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: endoscopic endonasal surgery with UPSIT
endoscopic endonasal surgery with UPSIT prior to surgery and at months 1, 3, 6, and 12 after surgery.
Procedure: endoscopic endonasal surgery with UPSIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with decreased olfactory function after endoscopic endonasal surgery
Time Frame: 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.
up to 12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ricardo L. Carrau, MD

Investigators

  • Principal Investigator: Ricardo Carrau, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014H0063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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