An observational study in Pituitary Tumors, sponsored by St. Joseph's Hospital and Medical Center, Phoenix. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by St. Joseph's Hospital and Medical Center, Phoenix · Observational
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.
175 studies on the registry are indexed under Pituitary Neoplasms; 48 are open to participants now.
This study's enrollment of 94 is below the median of 150 across 71 observational studies indexed under Pituitary Neoplasms.
Browse Pituitary Neoplasms studies →St. Joseph's Hospital and Medical Center, Phoenix is the lead sponsor of 63 studies on the registry; 11 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Neurosurgery and endocrinology clinic
Exclusion Criteria:
Single cohort of patients undergoing endonasal surgery
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
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
Eligible adult patients were identified in the outpatient neurosurgical clinics at the Barrow Neurological Institute between October 2010 and June 2011.
| Milestone | Endonasal Group | Control Group |
|---|---|---|
| Started | 52 | 42 |
| Completed | 52 | 42 |
| Not completed | 0 | 0 |
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.
| units on a scale | Endonasal Group | Control Group |
|---|---|---|
| Change in Mean Survey Response From Baseline to 90 Days Post Surgery | 17.3 ± 6.7 | 13.5 ± 4.2 |
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.
| Correlation Coefficient | Endonasal Group | Control Group |
|---|---|---|
| Test-retest Reliability of the ASK Nasal Inventory | 0.87 | 0.95 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Endonasal Group | — | 0/52 (0%) | 0/52 (0%) |
| Control Group | — | 0/42 (0%) | 0/42 (0%) |
| Age, Categorical(Participants) | Endonasal Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 32 | 73 |
| >=65 years | 11 | 10 | 21 |
| Age, Continuous(years) | Endonasal Group | Control Group | Total |
|---|---|---|---|
| Mean | 50 ± 15.49 | 54.17 ± 14.83 | 50.27 ± 15.26 |
| Sex: Female, Male(Participants) | Endonasal Group | Control Group | Total |
|---|---|---|---|
| Female | 25 | 24 | 49 |
| Male | 27 | 18 | 45 |
| Region of Enrollment(participants) | Endonasal Group | Control Group | Total |
|---|---|---|---|
| United States | 52 | 42 | 94 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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St. Joseph's Hospital and Medical Center, Phoenix