Olfactory Function Following Endoscopic Endonasal Skull Base Surgery

NCT02165969 | Terminated Results

• 1 other identifier: 2014H0063
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Skull Base Pathology

Keywords

tumor; inflammatory process; fracture; defect

Outcome Measures

Primary Outcomes (1)

• Changes in UPSIT Score for the Two Groups Undergoing Endoscopic Endonasal Surgery With or Without Flap

  We measured olfactory function using the University of Pennsylvania Smell Identification Test (UPSIT) in the two groups, with and without nasoseptal flap. UPSIT scores are measured out of 40: 34-40 - normal smell for men; 35-40 - normal smell for women; 30-33 - mild microsmia; 26-29 - moderate microsmia; 19-25 - severe microsmia; 18 or less - anosmia. Exact thresholds vary by age and sex. Official tables are available to refine diagnosis. Minimum score is 0, and maximum score is 40.

  up to 12 months post surgery

Study Arms (2)

patients undergoing EEA requiring a nasoseptal flap

endoscopic endonasal surgery undergoing a nasoseptal flap for reconstruction monitored with UPSIT prior to surgery and at months 1, 3, 6, and 12 after surgery.

Procedure: endoscopic endonasal surgery with UPSIT

patients undergoing EEA NOT requiring a nasoseptal flap followed up with UPSIT

endoscopic endonasal surgery NOT undergoing a nasoseptal flap for reconstruction monitored with UPSIT prior to surgery and at months 1, 3, 6, and 12 after surgery.

Procedure: endoscopic endonasal surgery with UPSIT

Interventions

endoscopic endonasal surgery with UPSIT PROCEDURE

patients undergoing EEA NOT requiring a nasoseptal flap followed up with UPSIT; patients undergoing EEA requiring a nasoseptal flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting with skull base pathologies requiring endonasal surgery

You may qualify if:

• Patients presenting with skull base pathologies requiring endonasal surgery at The Ohio State University Wexner Medical Center
• years or older
• Able to consent for self
• Negative serum pregnancy test for women of childbearing potential

You may not qualify if:

• Patient unable to return to clinic at specific follow-up times
• Pregnant or nursing
• Prisoners

Sponsors & Collaborators

• Ricardo L. Carrau, MD: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Neoplasms; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Dr Ricardo Carrau
• Organization: OSU Wexner Medical Center Department of Otolaryngology

Ricardo.Carrau@osumc.edu

614-293-8074

Study Officials

• Ricardo Carrau, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2014
• Primary Completion: October 25, 2017
• Study Completion: October 25, 2017
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Locations

US (1)