Acromegaly Clinical Trial
Official title:
Rhinological Outcomes in Endonasal Pituitary Surgery: A Multi-Center Observational Cohort Study
NCT number | NCT01504399 |
Other study ID # | 11BN093 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2011 |
Est. completion date | December 9, 2015 |
Verified date | August 2018 |
Source | St. Joseph's Hospital and Medical Center, Phoenix |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective, multi-center observational study designed to address patient-reported nasal outcomes in adults undergoing endoscopic and microscopic surgical removal of pituitary tumors. The primary objective of this study is to determine the difference in nasal outcomes by using the Anterior Skull Base (ASK) Nasal survey between patients treated with endoscopic surgical technique and those treated with microscopic surgical technique. Patients will be given the ASK Nasal survey to assess their nasal functioning and overall health before their surgery, and at post-operative visits 1-2 weeks, 3 months, and 6 months.
Status | Completed |
Enrollment | 235 |
Est. completion date | December 9, 2015 |
Est. primary completion date | June 1, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Pituitary tumor patients treated by transsphenoidal route - Adults (age 18-80 years) - Direct endonasal or endoscopic approach - Non-functioning adenoma, Cushing's disease, acromegaly Exclusion Criteria: - Patients treated by expanded endonasal approaches (transtubercular approach) - Sublabial approach |
Country | Name | City | State |
---|---|---|---|
United States | Northshore University Health System | Chicago | Illinois |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Barrow Neurological Institute/St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | John Wayne Cancer Institute at St. John's Health Center | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
St. Joseph's Hospital and Medical Center, Phoenix |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ASK Nasal symptom severity scores and SF-8 scores | Compare symptom severity scores and quality of life scores in first-time surgery patients with nonfunctioning adenomas on the ASK Nasal and SF-8. | 3 months | |
Primary | Validation of ASK Nasal survey tool | Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery. | 3 months | |
Secondary | ASK Nasal symptom severity scores | Evaluate the symptom severity scores on the ASK Nasal for first time surgery patients with nonfuctioning adenomas at the first post-operative visit and at 6 months. Evaluate the symptom severity scores on the ASK Nasal for all patients at the first post-operative visit and at 6 months. |
2 weeks, 3 months, 6 months postoperative | |
Secondary | Impact of surgical techniques and complications on ASK Nasal scores | Subgroup analysis on the impact of such surgical techniques, such as middle turbinate resection and nasal packing, on ASK Nasal scores will be performed. Subgroup analysis of rhinological complications, such as sinusitis, on ASK Nasal scores. Objective intranasal endoscopy findings at follow-up visits. |
6 months |
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