Olfactory Function Following Endoscopic Endonasal Skull Base Surgery (UPSIT)

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: Terminated
• Conditions: Skull Base Pathology
• Intervention / Treatment: Procedure: endoscopic endonasal surgery with UPSIT

Detailed Description

Preoperatively, every patient will undergo an olfactory evaluation using the University of Pennsylvania Smell IdentificationTest (UPSIT), comprising 40 "scratch and sniff" odorants. This test has been validated by age and gender. The test was re-administered at 6 weeks, 3 months, and 6 months following surgery (time window of 62 weeks). Timing of follow-up visits is based on previously published works suggesting that mucosal regeneration is complete in approximately 6 weeks, but return of ciliary function takes about 3 months.17 Furthermore, the reported persistence of nasal crusting up to 100 days after surgery warrants a 6-month (minimum)visit to assess possible delayed recovery of olfaction.

Pertinent data will be collected, including patient demographics, relevant medical/surgical history, and nasal symptoms. Operative data regarding the surgical approach and the type of reconstructive flaps were also recorded. Postoperative course in reference to epistaxis, CSF leak, or need for revision surgery was also documented. To better define the cohort,patients will be categorized into two groups: group I, patients who underwent a nasoseptal flap reconstruction; and group II,patients who underwent rescue flap technique.

Nonparametric data will be analyzed using the Wilcoxon signed rank test and the Mann-Whitney test to allow the intra and intergroup comparison of preoperative and postoperative scores. All statistical analysis will be performed using SPSS v20(IBM, Armonk, NY). All probability values were two-tailed, andP < .05 is considered statistically significant.

• Study Type: Observational
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting with skull base pathologies requiring endonasal surgery

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ricardo L. Carrau, MD
• Investigators: Principal Investigator: Ricardo Carrau, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 25, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimated): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: fracture; tumor; defect; inflammatory process
• Additional Relevant MeSH Terms: Wounds and Injuries; Neoplasms; Fractures, Bone
• Other Study ID Numbers: 2014H0063