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
|Condition or disease||Intervention/treatment||Phase|
|Skull Base Pathology||Procedure: endoscopic endonasal surgery with UPSIT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|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|
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
- 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.
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
|Contact: Amanda McGill, MA||614-685-8622||Amanda.McGill@osumc.edu|
|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|
|Principal Investigator:||Ricardo Carrau, MD||Ohio State University|