Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

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.

This prospective study, coupled with the results of the recent POET study evaluating the role of antibiotics in postoperative outcomes for pituitary surgery, will guide physicians in the optimal management of patients following endoscopic pituitary surgery.

The investigator group has an established record of completing multicenter studies (e.g., POET, TRANSPHER) that have influenced clinical practice guidelines, raised the profile of Barrow in the pituitary and skull base community, and resulted in numerous peer-reviewed publications and awards.

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