Trial Outcomes & Findings for Olfactory Function Following Endoscopic Endonasal Skull Base Surgery (NCT NCT02165969)

Last Updated: 2026-04-27

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

50 participants

Primary outcome timeframe

up to 12 months post surgery

Results posted on

2026-04-27

Participant Flow

Patients recruited at Ohio Wexner Medical Center.

Participant milestones

Participant milestones
Measure	Endoscopic Endonasal Surgery With Flap (UPSIT) endoscopic endonasal surgery with flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.	Endoscopic Endonasal Surgery Without Flap (With UPSIT) endoscopic endonasal surgery without flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.
Endoscopic Endonasal Surgery Consent STARTED	15	35
Endoscopic Endonasal Surgery Consent COMPLETED	10	35
Endoscopic Endonasal Surgery Consent NOT COMPLETED	5	0
Endoscopic Endonasal Surgery Completion STARTED	10	35
Endoscopic Endonasal Surgery Completion COMPLETED	10	35
Endoscopic Endonasal Surgery Completion NOT COMPLETED	0	0
1 Month Follow-Up STARTED	10	35
1 Month Follow-Up COMPLETED	10	35
1 Month Follow-Up NOT COMPLETED	0	0
3 Month Follow Up STARTED	10	35
3 Month Follow Up COMPLETED	10	35
3 Month Follow Up NOT COMPLETED	0	0
6 Month Follow Up STARTED	10	35
6 Month Follow Up COMPLETED	10	35
6 Month Follow Up NOT COMPLETED	0	0
12 Month Follow Up STARTED	10	35
12 Month Follow Up COMPLETED	10	35
12 Month Follow Up NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Endoscopic Endonasal Surgery With Flap (UPSIT) endoscopic endonasal surgery with flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.	Endoscopic Endonasal Surgery Without Flap (With UPSIT) endoscopic endonasal surgery without flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.
Endoscopic Endonasal Surgery Consent Lost to Follow-up	5	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endoscopic Endonasal Surgery With Flap (With UPSIT) n=10 Participants endoscopic endonasal surgery with flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.	Endoscopic Endonasal Surgery Without Flap (With UPSIT) n=35 Participants endoscopic endonasal surgery without flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=10 Participants	0 Participants n=35 Participants	0 Participants n=45 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=10 Participants	35 Participants n=35 Participants	45 Participants n=45 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants	0 Participants n=35 Participants	0 Participants n=45 Participants
Age, Continuous	45.5 years n=10 Participants	48.9 years n=35 Participants	47.2 years n=45 Participants
Sex: Female, Male Female	6 Participants n=10 Participants	17 Participants n=35 Participants	23 Participants n=45 Participants
Sex: Female, Male Male	4 Participants n=10 Participants	18 Participants n=35 Participants	22 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	35 participants n=35 Participants	45 participants n=45 Participants
UPSIT Score	30.7 Score on a scale n=10 Participants	31.5 Score on a scale n=35 Participants	31.1 Score on a scale n=45 Participants

PRIMARY outcome

Timeframe: up to 12 months post surgery

Population: Fifty patients were enrolled in the study; however,five patients failed to follow up on a regular basis and thus were excluded from the data analysis. Ten patients underwent reconstruction with an NSF, and the other 35 patients underwent a rescue flap technique.

Outcome measures

Outcome measures
Measure	Endoscopic Endonasal Surgery With Flap (With UPSIT) n=10 Participants endoscopic endonasal surgery flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.	Endoscopic Endonasal Surgery Without Flap (With UPSIT) n=35 Participants endoscopic endonasal surgery without flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.
Changes in UPSIT Score for the Two Groups Undergoing Endoscopic Endonasal Surgery With or Without Flap Preoperative	30.7 score on a scale Interval 0.0 to 40.0	31.5 score on a scale Interval 0.0 to 40.0
Changes in UPSIT Score for the Two Groups Undergoing Endoscopic Endonasal Surgery With or Without Flap Postoperative	30.0 score on a scale Interval 25.0 to 40.0	33.7 score on a scale Interval 25.0 to 40.0

Adverse Events

Endoscopic Endonasal Surgery With Flap (With UPSIT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Endoscopic Endonasal Surgery Without Flap (With UPSIT)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Endoscopic Endonasal Surgery With Flap (With UPSIT) n=10 participants at risk endoscopic endonasal surgery with flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.	Endoscopic Endonasal Surgery Without Flap (With UPSIT) n=35 participants at risk endoscopic endonasal surgery without flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.
Respiratory, thoracic and mediastinal disorders Bleeding	0.00% 0/10 • 6 months There is no risk of serious adverse events, or mortality or other due to the nature of the smell test (it is a scratch and sniff test that includes daily encountered smells. Complications of the surgeries (indications as per standard of care) are not part of the study but were noted and reported.	2.9% 1/35 • Number of events 1 • 6 months There is no risk of serious adverse events, or mortality or other due to the nature of the smell test (it is a scratch and sniff test that includes daily encountered smells. Complications of the surgeries (indications as per standard of care) are not part of the study but were noted and reported.

Other adverse events

Adverse event data not reported

Additional Information

Dr Ricardo Carrau

OSU Wexner Medical Center Department of Otolaryngology

Phone: 614-293-8074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place