Pituitary Tumor Clinical Trial
— NOSEOfficial title:
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
This is a prospective, single-blinded, multicenter study evaluating the benefit of sinonasal irrigations following endoscopic pituitary surgery. The goal of this study is to create practice changing guidelines with objective data highlighting the importance of irrigations on postoperative outcomes for pituitary surgery.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2029 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 85 Years |
Eligibility | Inclusion criteria 1. Adult patient undergoing endoscopic surgery for resection of pituitary tumors - nonfunctioning adenoma - acromegaly - prolactinoma - Rathke's cleft cyst 2. Adults >18 and <85 years of age 3. English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales 4. Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable 5. Planned binostril surgical approach 6. Either with or without septal flap reconstruction 7. Either with or without septoplasty Exclusion criteria 1. Active sinus infection 2. Allergic rhinitis 3. Asthma 4. Vascular or inflammatory disease 5. History of previous sinonasal surgery 6. Any subject who is unwilling or unable to sign informed consent for the study 7. Pregnancy 8. Incarcerated patients 9. Cushing's disease 10. History of chronic sinusitis 11. Extended approaches to the skull base 12. Active sinusitis 13. Nasal polyps 14. Concurrent antibiotics for another indication (i.e., urinary tract infection) 15. Immunodeficiency 16. History of radiation to the skull base |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Barrow Neurological Institute at St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Lori Wood | Barrow Brain and Spine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in mean sinonasal quality of life | Difference in mean sinonasal quality of life between groups as determined by patient reported Sino-nasal Outcome Test (SNOT-22) scores at 4 weeks. SNOT-22 scoring can be completed during a clinic visit or by phone interview. It is critical that the follow-up times are standardized because symptoms improve with time. A reduction in SNOT-22 composite score is indicative of improvement in symptoms. | 12 weeks | |
Secondary | Endoscopy findings | Postoperative nasal endoscopy findings of purulence, nasal crusting, polyps, and synechiae as estimated on the Endoscopic Appearances scale developed by Lund- Kennedy at 1 week, 4 weeks, and 12 weeks after surgery. | 12 weeks | |
Secondary | Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores | Sinonasal quality of life as determined by patient-reported ASK Nasal-12 scores at
1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after surgery. |
12 weeks | |
Secondary | Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) | Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) overall scores at 1week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery. | 12 weeks | |
Secondary | Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores | Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores at 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery. | 12 weeks | |
Secondary | Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction. | Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction. | 12 weeks |
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