Evaluating nasal saline irrigations after pituitary surgery
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
This study tests if using nasal saline rinses after pituitary surgery can help patients recover better and improve their overall results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | St. Joseph's Hospital and Medical Center, Phoenix Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT05659524 on ClinicalTrials.gov |
What this trial studies
This prospective, single-blinded, multicenter study investigates the effects of sinonasal irrigations following endoscopic pituitary surgery. The aim is to gather objective data that will inform practice-changing guidelines regarding postoperative care for patients undergoing this type of surgery. By analyzing outcomes in patients who receive nasal saline irrigations, the study seeks to enhance recovery and overall surgical results. The findings will build on previous research, including the POET study, to optimize patient management post-surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 undergoing endoscopic surgery for the resection of pituitary tumors.
Not a fit: Patients with active sinus infections, chronic sinusitis, or those who have had previous sinonasal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes for patients undergoing pituitary surgery.
How similar studies have performed: Previous multicenter studies in this area have influenced clinical practice guidelines, suggesting a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Phoenix, Arizona and 1 other locations
- Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Val Calores
- Email: Val.calores@dignityhealth.org
- Phone: 602-406-8772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.