Pituitary Tumors
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
St. Joseph's Hospital and Medical Center, Phoenix
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults with planned endonasal surgery for pituitary tumor or skull base lesion
Exclusion criteria
* Children
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Survey Response From Baseline to 90 Days Post Surgery | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test-retest Reliability of the ASK Nasal Inventory | 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. |
Countries
United States
Participant flow
Recruitment details
Eligible adult patients were identified in the outpatient neurosurgical clinics at the Barrow Neurological Institute between October 2010 and June 2011.
Participants by arm
| Arm | Count |
|---|---|
| Endonasal Group Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques. | 52 |
| 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. | 42 |
| Total | 94 |
Baseline characteristics
| Characteristic | Control Group | Endonasal Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 41 Participants | 73 Participants |
| Age, Continuous | 54.17 years STANDARD_DEVIATION 14.83 | 50 years STANDARD_DEVIATION 15.49 | 50.27 years STANDARD_DEVIATION 15.26 |
| Region of Enrollment United States | 42 participants | 52 participants | 94 participants |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 49 Participants |
| Sex: Female, Male Male | 18 Participants | 27 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 42 |
| serious Total, serious adverse events | 0 / 52 | 0 / 42 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endonasal Group | Change in Mean Survey Response From Baseline to 90 Days Post Surgery | 17.3 units on a scale | Standard Deviation 6.7 |
| Control Group | Change in Mean Survey Response From Baseline to 90 Days Post Surgery | 13.5 units on a scale | Standard Deviation 4.2 |
p-value: 0.001t-test, 2 sided
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.
Time frame: 90 days and 120 days post surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endonasal Group | Test-retest Reliability of the ASK Nasal Inventory | 0.87 Correlation Coefficient |
| Control Group | Test-retest Reliability of the ASK Nasal Inventory | 0.95 Correlation Coefficient |