Barrow Nasal Inventory Survey

Pituitary Tumors Clinical Trial

— BNI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322945
• Other study ID #: 10BN172
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: December 9, 2013
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2013
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults with planned endonasal surgery for pituitary tumor or skull base lesion

Exclusion Criteria:

• Children

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pituitary Neoplasms
• Pituitary Tumors

Locations

Country	Name	City	State
United States	Barrow Neurological Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

References & Publications (1)

Little AS, Jahnke H, Nakaji P, Milligan J, Chapple K, White WL. The anterior skull base nasal inventory (ASK nasal inventory): a clinical tool for evaluating rhinological outcomes after endonasal surgery for pituitary and cranial base lesions. Pituitary. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Survey Response From Baseline to 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.	Baseline, 90 days post surgery	No
Secondary	Test-retest Reliability of the ASK Nasal Inventory	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.	90 days and 120 days post surgery	No