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Olfactory Function Following Endoscopic Endonasal Skull Base Surgery (UPSIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165969
Recruitment Status : Unknown
Verified March 2017 by Ricardo L. Carrau, MD, Ohio State University.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ricardo L. Carrau, MD, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Skull Base Pathology Procedure: endoscopic endonasal surgery with UPSIT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Olfactory Function Following Endoscopic Endonasal Skull Base Surgery: Clinical and Histological Outcomes
Study Start Date : June 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165969


Contacts
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Contact: Amanda McGill, MA 614-685-8622 Amanda.McGill@osumc.edu

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Amanda McGill, MS    614-685-8622    Amanda.McGill@osumc.edu   
Principal Investigator: Ricardo Carrau, MD         
Sponsors and Collaborators
Ricardo L. Carrau, MD
Investigators
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Principal Investigator: Ricardo Carrau, MD Ohio State University
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Responsible Party: Ricardo L. Carrau, MD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02165969    
Other Study ID Numbers: 2014H0063
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Ricardo L. Carrau, MD, Ohio State University:
tumor
inflammatory process
fracture
defect