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Per PI request upon data analysis limitation discovery.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic endonasal surgery with UPSIT | Procedure |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients presenting with skull base pathologies requiring endonasal surgery
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Carrau, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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Patients recruited at Ohio Wexner Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endoscopic Endonasal Surgery Consent |
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| Endoscopic Endonasal Surgery Completion |
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| 1 Month Follow-Up |
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| 3 Month Follow Up |
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| 6 Month Follow Up |
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| 12 Month Follow Up |
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Fifty consecutive patients were enrolled in the study; however, five patients failed to follow up; thus were excluded from the data analysis. Ten patients underwent reconstruction with an NSF, and the other 35 patients did not. For Group I, mean age was 45.5 yr.
Group II included 18 males and 17 females; mean age 48.9 years.
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| ID | Title | Description |
|---|---|---|
| BG000 | Endoscopic Endonasal Surgery With Flap (With UPSIT) | endoscopic endonasal surgery with flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery. |
| BG001 | Endoscopic Endonasal Surgery Without Flap (With UPSIT) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Full Range | score on a scale | up to 12 months post surgery |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endoscopic Endonasal Surgery With Flap (With UPSIT) | endoscopic endonasal surgery with flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Respiratory, thoracic and mediastinal disorders | Epistaxis | Non-systematic Assessment | Posterior epistaxis requiring cauterization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ricardo Carrau | OSU Wexner Medical Center Department of Otolaryngology | 614-293-8074 | Ricardo.Carrau@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2014 | Dec 14, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 13, 2017 | Mar 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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endoscopic endonasal surgery without flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| UPSIT Score | 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. | Mean | Full Range | Score on a scale |
|
endoscopic endonasal surgery flap (with UPSIT) prior to surgery and at months 1, 3, 6, and 12 after surgery. |
| OG001 | 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. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 35 | 1 | 35 | 0 | 35 |
|
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