Rhinological Outcomes in Endonasal Pituitary Surgery
1 other identifier
observational
235
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2015
CompletedAugust 22, 2018
August 1, 2018
2.7 years
January 3, 2012
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Validation of ASK Nasal survey tool
Validate a nasal outcomes scale (ASK Nasal) specifically designed for anterior skull base surgery.
3 months
Secondary Outcomes (2)
ASK Nasal symptom severity scores
2 weeks, 3 months, 6 months postoperative
Impact of surgical techniques and complications on ASK Nasal scores
6 months
Study Arms (2)
Microscopic:
Microscopic (single nostril, direct endonasal with nasal speculum)transsphenoidal nasal surgery
Endoscopic
Fully endoscopic: (bi-nostril, no nasal speculum) transsphenoidal pituitary surgery
Eligibility Criteria
Patients with pituitary lesions referred to our investigators for surgical management by either microscopic or endoscopic transspenoidal surgical resection.
You may qualify if:
- Pituitary tumor patients treated by transsphenoidal route
- Adults (age 18-80 years)
- Direct endonasal or endoscopic approach
- Non-functioning adenoma, Cushing's disease, acromegaly
You may not qualify if:
- Patients treated by expanded endonasal approaches (transtubercular approach)
- Sublabial approach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
John Wayne Cancer Institute at St. John's Health Center
Santa Monica, California, 90404, United States
Northshore University Health System
Chicago, Illinois, 60640, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Publications (5)
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.
PMID: 22038032BACKGROUNDZaidi HA, Awad AW, Bohl MA, Chapple K, Knecht L, Jahnke H, White WL, Little AS. Comparison of outcomes between a less experienced surgeon using a fully endoscopic technique and a very experienced surgeon using a microscopic transsphenoidal technique for pituitary adenoma. J Neurosurg. 2016 Mar;124(3):596-604. doi: 10.3171/2015.4.JNS15102. Epub 2015 Oct 16.
PMID: 26473774DERIVEDLittle AS, Kelly DF, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study. J Neurosurg. 2015 Sep;123(3):799-807. doi: 10.3171/2014.10.JNS14921. Epub 2015 Apr 17.
PMID: 25884256DERIVEDLittle AS, Kelly D, Milligan J, Griffiths C, Prevedello DM, Carrau RL, Rosseau G, Barkhoudarian G, Otto BA, Jahnke H, Chaloner C, Jelinek KL, Chapple K, White WL. Predictors of sinonasal quality of life and nasal morbidity after fully endoscopic transsphenoidal surgery. J Neurosurg. 2015 Jun;122(6):1458-65. doi: 10.3171/2014.10.JNS141624. Epub 2015 Apr 3.
PMID: 25839931DERIVEDLittle AS, Kelly D, Milligan J, Griffiths C, Rosseau G, Prevedello DM, Carrau R, Jahnke H, Chaloner C, O'Leary J, Chapple K, Nakaji P, White WL. Prospective validation of a patient-reported nasal quality-of-life tool for endonasal skull base surgery: The Anterior Skull Base Nasal Inventory-12. J Neurosurg. 2013 Oct;119(4):1068-74. doi: 10.3171/2013.3.JNS122032. Epub 2013 May 10.
PMID: 23662829DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew S. Little, MD
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 5, 2012
Study Start
October 1, 2011
Primary Completion
June 1, 2014
Study Completion
December 9, 2015
Last Updated
August 22, 2018
Record last verified: 2018-08