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

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.

Study Overview

• Status: Recruiting
• Conditions: Pituitary Tumor
• Intervention / Treatment: Other: Nasal saline irrigation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Val Calores; Phone Number: 602-406-8772; Email: Val.calores@dignityhealth.org
• Study Contact Backup: Name: Malika Bhargava; Phone Number: 602-406-7121; Email: Malika.Bhargava@dignityhealth.org

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
      • Principal Investigator: Andrew Little, MD
      • Sub-Investigator: Griffith Santarelli, MD
      • Contact: Val Calores; Phone Number: 602-406-8772; Email: Val.calores@dignityhealth.org
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Varun Kshettry, MD
      • Contact: Teresa Allison; Phone Number: 216-444-6459; Email: ALLISOT@ccf.or

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nasal saline irrigation; Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations	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.
No Intervention: No Intervention; Patients randomized to not performing saline sinonasal irrigations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Lori Wood
• Collaborators: Barrow Brain and Spine

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: PHX-20-500-189-30-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study is IRB approved to share deidentified data outside of the institution, with presence of a valid data sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No