Clinical Trial: Barrow Nasal Inventory Survey

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational Study of Nasal Outcomes Following Endonasal Surgery for Anterior Skull Base Lesions

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Current Primary Outcome: Change in Mean Survey Response From Baseline to 90 Days Post Surgery [ Time Frame: Baseline, 90 days post surgery ]

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.


Original Primary Outcome: Patient perception of change in nasal functioning [ Time Frame: 90 days ]

A survery asking patients about the functioning of their nose will be administered to patients before endonasal surgery and ninety days after to determine if there is a change in functioning.


Current Secondary Outcome: Test-retest Reliability of the ASK Nasal Inventory [ Time Frame: 90 days and 120 days post surgery ]

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.


Original Secondary Outcome:

Information By: St. Joseph's Hospital and Medical Center, Phoenix

Dates:
Date Received: March 23, 2011
Date Started: October 2010
Date Completion:
Last Updated: December 9, 2013
Last Verified: December 2013