Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Pituitary Tumor Clinical Trial

— NOSE  

Official title:

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659524
• Other study ID #: PHX-20-500-189-30-12
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: Val Calores
• Phone: 602-406-8772
• Email: Val.calores[@]dignityhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

Other:
• Nasal saline irrigation
The following nasal care recommendations have been approved by the study protocol committee for patients randomized to the treatment arm with saline irrigations: Postoperative days 1 through 3: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative day 3 to week 12: patients will begin twice daily sinus irrigation rinse (e.g., NeilMed Sinus Rinse). They will perform 240 mL sinus rinses BID. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Lori Wood	Barrow Brain and Spine

Country where clinical trial is conducted

United States, 

Outcome

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