Skull Base PathologyUPSITNCT02165969
Olfactory Function Following Endoscopic Endonasal Skull Base Surgery
An observational study of Skull Base Pathology, run by Ricardo L. Carrau, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skull Base Pathology
- What is being tested?
- endoscopic endonasal surgery with UPSIT
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 25 Oct 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting with skull base pathologies requiring endonasal surgery
Who may be able to join
- 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
Who cannot join
- Patient unable to return to clinic at specific follow-up times
- Pregnant or nursing
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Skull Base Pathology
- Being tested
- endoscopic endonasal surgery with UPSIT
- Keywords
- tumor, inflammatory process, fracture, defect
- Medical subject headings
- Neoplasms, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic endonasal surgery with UPSITProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: endoscopic endonasal surgery with UPSIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
Why it stopped: Per PI request upon data analysis limitation discovery.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skull Base PathologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ricardo L. Carrau, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo L. Carrau, MD, Ohio State University
- Investigators
- Ricardo Carrau, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165969
- Sponsor's protocol ID
- 2014H0063
- Acronym
- UPSIT
- Status last verified
- Apr 2026
- First submitted
- 23 May 2014
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Function Following Endoscopic Endonasal Skull Base Surgery: Clinical and Histological Outcomes
- ClinicalTrials.gov ID
- NCT02165969
- Acronym / sponsor ID
- UPSIT / 2014H0063
- Conditions
- Skull Base Pathology
- Keywords
- tumor, inflammatory process, fracture, defect
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Per PI request upon data analysis limitation discovery.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ricardo L. Carrau, MDUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients undergoing EEA requiring a nasoseptal flap | – | Procedure: endoscopic endonasal surgery with UPSITendoscopic endonasal surgery undergoing a nasoseptal flap for reconstruction monitored with UPSIT prior to surgery and at months 1, 3, 6, and 12 after surgery. |
| patients undergoing EEA NOT requiring a nasoseptal flap followed up with UPSIT | – | Procedure: endoscopic endonasal surgery with UPSITendoscopic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting with skull base pathologies requiring endonasal surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient unable to return to clinic at specific follow-up times
- Pregnant or nursing
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic endonasal surgery with UPSIT | Procedure or surgery | patients undergoing EEA NOT requiring a nasoseptal flap followed up with UPSIT, patients undergoing EEA requiring a nasoseptal flap |
Primary outcome
Changes in UPSIT Score for the Two Groups Undergoing Endoscopic Endonasal Surgery With or Without Flap
Time frame: up to 12 months post surgery
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Carrau, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skull Base Pathology, run by Ricardo L. Carrau, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in UPSIT Score for the Two Groups Undergoing Endoscopic Endonasal Surgery With or Without Flap (time frame: up to 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.