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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endonasal surgery | Single cohort of patients undergoing endonasal surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Neurosurgery and endocrinology clinic
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Little, MD | Barrow Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22038032 | Result | 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. 2012 Dec;15(4):513-7. doi: 10.1007/s11102-011-0358-4. |
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Eligible adult patients were identified in the outpatient neurosurgical clinics at the Barrow Neurological Institute between October 2010 and June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endonasal Group | Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endonasal Group | Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Power analyses were conducted to determine a sample size large enough to significantly detect change with 90% power using a pre- post research methodology. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 90 days post surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endonasal Group | Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew S. Little, MD | Barrow Neurological Institute | 602-406-3181 | heidi.jahnke@dignityhealth.org |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| 90 days and 120 days post surgery |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
| OG001 | 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. |
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| 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. | Posted | Number | Correlation Coefficient | 90 days and 120 days post surgery |
|
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|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | 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. | 0 | 42 | 0 | 42 |
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| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |