Skull Base Pathology
Conditions
Keywords
tumor, inflammatory process, fracture, defect
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.
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.
Interventions
PROCEDUREendoscopic endonasal surgery with UPSIT
Sponsors
Ricardo L. Carrau, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in UPSIT Score for the Two Groups Undergoing Endoscopic Endonasal Surgery With or Without Flap | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRicardo Carrau, MD
Ohio State University
Participant flow
Recruitment details
Patients recruited at Ohio Wexner Medical Center.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 47.2 years |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 4 Participants |
| UPSIT Score | 31.1 Score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 35 |
| other Total, other adverse events | 0 / 10 | 0 / 35 |
| serious Total, serious adverse events | 0 / 10 | 1 / 35 |
Outcome results
None listed