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 ]
Original Primary Outcome: Patient perception of change in nasal functioning [ Time Frame: 90 days ]
Current Secondary Outcome: Test-retest Reliability of the ASK Nasal Inventory [ Time Frame: 90 days and 120 days post surgery ]
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