Trial Outcomes & Findings for Barrow Nasal Inventory Survey (NCT NCT01322945)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

94 participants

Primary outcome timeframe

Baseline, 90 days post surgery

Results posted on

2013-12-10

Participant Flow

Eligible adult patients were identified in the outpatient neurosurgical clinics at the Barrow Neurological Institute between October 2010 and June 2011.

Participant milestones

Participant milestones
Measure	Endonasal Group Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.	Control Group 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 Study STARTED	52	42
Overall Study COMPLETED	52	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Barrow Nasal Inventory Survey

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endonasal Group n=52 Participants Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.	Control Group n=42 Participants 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 n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	32 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 15.49 • n=5 Participants	54.17 years STANDARD_DEVIATION 14.83 • n=7 Participants	50.27 years STANDARD_DEVIATION 15.26 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	18 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	42 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 90 days post surgery

Population: Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology.

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.

Outcome measures

Outcome measures
Measure	Endonasal Group n=52 Participants Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.	Control Group n=42 Participants 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.
Change in Mean Survey Response From Baseline to 90 Days Post Surgery	17.3 units on a scale Standard Deviation 6.7	13.5 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Endonasal Group n=12 Participants Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.	Control Group n=10 Participants 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.
Test-retest Reliability of the ASK Nasal Inventory	0.87 Correlation Coefficient	0.95 Correlation Coefficient

Adverse Events

Endonasal Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew S. Little, MD

Barrow Neurological Institute

Phone: 602-406-3181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place