Barrow Nasal Inventory Survey (BNI)
The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery. This type of surgery is conducted for pituitary and skull base tumors. There is no published data on trauma to the nose during surgery and how it impacts nasal functioning. The investigators propose to develop a survey and administer it to patients before and after surgery to learn about their perception of nasal functioning.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Study of Nasal Outcomes Following Endonasal Surgery for Anterior Skull Base Lesions|
- Change in Mean Survey Response From Baseline to 90 Days Post Surgery [ Time Frame: Baseline, 90 days post surgery ] [ Designated as safety issue: No ]Mean survey response at 90 days post surgery between the control patients and the endonasal surgery patients using the Anterior skull base nasal inventory (ASK Nasal Inventory. A 5-point Likert scale for each question on the ASK Nasal inventory measures frequency of nasal symptoms where 1=never, 2= a little of the time, 3=some of the time, 4=most of the time, 5= all of the time. Total mean Likert scores were compared in the endonasal group to the control group after surgery. Scores range from minimum of 9 to maximum of 45. The lower the score the fewer the nasal complaints.
- Test-retest Reliability of the ASK Nasal Inventory [ Time Frame: 90 days and 120 days post surgery ] [ Designated as safety issue: No ]First 12 endonasal and 10 control patients enrolled in the study completed the ASK Nasal Inventory at 90 days and 120 days post surgery to measure reliablity of the survey (they scored the 9-item instrument similarly at both time frames)comparing 5-point Likert scale scores. Pearson correlation was used to determine a correlation between each patient's responses at 90 days post op and 120 days post op.
|Study Start Date:||October 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Single cohort of patients undergoing endonasal surgery
A 9-item patient survey (the ASK Nasal Inventory) focusing on the most common postoperative complaints, such as crusting, sinusitis, pain, and ease of breathing, was developed by the anterior skull base team at the Barrow Neurological Institute. Content was validated in structured patient interviews by four subject-matter experts with both endonasal and control groups. Eligible patients for the control group included patients undergoing any neurosurgical procedure requiring anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, and shunting procedures. This survey was self-administered pre- and 3 months post-surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322945
|United States, Arizona|
|Barrow Neurological Institute|
|Phoenix, Arizona, United States, 85013|
|Principal Investigator:||Andrew Little, MD||Barrow Neurological Institute|