Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery (NOSE)

Lori Wood

Status: Enrolling

Conditions: Pituitary Tumor

Treatments: Other: Nasal saline irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05659524

PHX-20-500-189-30-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

140 participants in 2 patient groups

Nasal saline irrigation

Active Comparator group

Description:

Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations

Treatment:

Other: Nasal saline irrigation

No Intervention

No Intervention group

Description:

Patients randomized to not performing saline sinonasal irrigations.