- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01322945
Barrow Nasal Inventory Survey (BNI)
December 9, 2013 updated by: St. Joseph's Hospital and Medical Center, Phoenix
Observational Study of Nasal Outcomes Following Endonasal Surgery for Anterior Skull Base Lesions
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
94
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neurosurgery and endocrinology clinic
Description
Inclusion Criteria:
- Adults with planned endonasal surgery for pituitary tumor or skull base lesion
Exclusion Criteria:
- Children
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Endonasal surgery
Single cohort of patients undergoing endonasal surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Survey Response From Baseline to 90 Days Post Surgery
Time Frame: Baseline, 90 days post surgery
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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.
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Baseline, 90 days post surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Test-retest Reliability of the ASK Nasal Inventory
Time Frame: 90 days and 120 days post surgery
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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.
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90 days and 120 days post surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Little, MD, Barrow Neurological Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
June 1, 2011
Study Registration Dates
First Submitted
March 23, 2011
First Submitted That Met QC Criteria
March 24, 2011
First Posted (ESTIMATE)
March 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 10, 2013
Last Update Submitted That Met QC Criteria
December 9, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Pituitary Diseases
- Pituitary Neoplasms
Other Study ID Numbers
- 10BN172
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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