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Barrow Nasal Inventory Survey (BNI)

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ClinicalTrials.gov Identifier: NCT01322945
Recruitment Status : Completed
First Posted : March 25, 2011
Results First Posted : December 10, 2013
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pituitary Tumors
Enrollment 94
Recruitment Details Eligible adult patients were identified in the outpatient neurosurgical clinics at the Barrow Neurological Institute between October 2010 and June 2011.
Pre-assignment Details  
Arm/Group Title Endonasal Group Control Group
Hide Arm/Group Description Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques. Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
Period Title: Overall Study
Started 52 42
Completed 52 42
Not Completed 0 0
Arm/Group Title Endonasal Group Control Group Total
Hide Arm/Group Description Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques. Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures. Total of all reporting groups
Overall Number of Baseline Participants 52 42 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 42 participants 94 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
  78.8%
32
  76.2%
73
  77.7%
>=65 years
11
  21.2%
10
  23.8%
21
  22.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 42 participants 94 participants
50  (15.49) 54.17  (14.83) 50.27  (15.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 42 participants 94 participants
Female
25
  48.1%
24
  57.1%
49
  52.1%
Male
27
  51.9%
18
  42.9%
45
  47.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 42 participants 94 participants
52 42 94
1.Primary Outcome
Title Change in Mean Survey Response From Baseline to 90 Days Post Surgery
Hide Description 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.
Time Frame Baseline, 90 days post surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.
Arm/Group Title Endonasal Group Control Group
Hide Arm/Group Description:
Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
Overall Number of Participants Analyzed 52 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.3  (6.7) 13.5  (4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endonasal Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Test-retest Reliability of the ASK Nasal Inventory
Hide Description 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.
Time Frame 90 days and 120 days post surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endonasal Group Control Group
Hide Arm/Group Description:
First 12 patients enrolled undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
First 10 patients enrolled undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
Overall Number of Participants Analyzed 12 10
Measure Type: Number
Unit of Measure: Correlation Coefficient
0.87 0.95
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endonasal Group Control Group
Hide Arm/Group Description Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques. Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
All-Cause Mortality
Endonasal Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Endonasal Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Endonasal Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/42 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Andrew S. Little, MD
Organization: Barrow Neurological Institute
Phone: 602-406-3181
Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01322945     History of Changes
Other Study ID Numbers: 10BN172
First Submitted: March 23, 2011
First Posted: March 25, 2011
Results First Submitted: January 30, 2013
Results First Posted: December 10, 2013
Last Update Posted: December 10, 2013