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

Primary Purpose

Pituitary Tumor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal saline irrigation
Sponsored by
Nicole Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pituitary Tumor

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Adult patient undergoing endoscopic surgery for resection of pituitary tumors nonfunctioning adenoma acromegaly prolactinoma Rathke's cleft cyst Adults >18 and <85 years of age English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable Planned binostril surgical approach Either with or without septal flap reconstruction Either with or without septoplasty Exclusion criteria Active sinus infection Allergic rhinitis Asthma Vascular or inflammatory disease History of previous sinonasal surgery Any subject who is unwilling or unable to sign informed consent for the study Pregnancy Incarcerated patients Cushing's disease History of chronic sinusitis Extended approaches to the skull base Active sinusitis Nasal polyps Concurrent antibiotics for another indication (i.e., urinary tract infection) Immunodeficiency History of radiation to the skull base

Sites / Locations

  • Barrow Neurological Institute at St. Joseph's Hospital and Medical CenterRecruiting
  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Nasal saline irrigation

No Intervention

Arm Description

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

Patients randomized to not performing saline sinonasal irrigations.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 29, 2021
Last Updated
December 19, 2022
Sponsor
Nicole Hill
Collaborators
Barrow Brain and Spine
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1. Study Identification

Unique Protocol Identification Number
NCT05659524
Brief Title
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
Acronym
NOSE
Official Title
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicole Hill
Collaborators
Barrow Brain and Spine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter randomized single-blinded, intervention trial involving 70 patients from this site (140 treated patients total from all sites), undergoing endoscopic transsphenoidal surgery for pituitary lesions. The same cohort will simultaneously be used to evaluate the role of sinonasal irrigations in those patients who undergo nasoseptal flap reconstructive procedures as part of their treatment.
Masking
Care Provider
Masking Description
The study will be blinded to the Otolaryngologist involved in the study. The research team and the patient will not be blinded. The goal of blinding the Otolaryngologist is to minimize the bias in grading the Lund Kennedy endoscopic scores which are a subjective metric interpreted in the office setting.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal saline irrigation
Arm Type
Active Comparator
Arm Description
Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Patients randomized to not performing saline sinonasal irrigations.
Intervention Type
Other
Intervention Name(s)
Nasal saline irrigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in mean sinonasal quality of life
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Endoscopy findings
Description
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.
Time Frame
12 weeks
Title
Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores
Description
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.
Time Frame
12 weeks
Title
Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22)
Description
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.
Time Frame
12 weeks
Title
Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores
Description
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.
Time Frame
12 weeks
Title
Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction.
Description
Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Adult patient undergoing endoscopic surgery for resection of pituitary tumors nonfunctioning adenoma acromegaly prolactinoma Rathke's cleft cyst Adults >18 and <85 years of age English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable Planned binostril surgical approach Either with or without septal flap reconstruction Either with or without septoplasty Exclusion criteria Active sinus infection Allergic rhinitis Asthma Vascular or inflammatory disease History of previous sinonasal surgery Any subject who is unwilling or unable to sign informed consent for the study Pregnancy Incarcerated patients Cushing's disease History of chronic sinusitis Extended approaches to the skull base Active sinusitis Nasal polyps Concurrent antibiotics for another indication (i.e., urinary tract infection) Immunodeficiency History of radiation to the skull base
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Hill
Phone
602-406-7034
Email
nicole.hill2@dignityhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Wood
Phone
602-406-9769
Email
Lori.Wood@dignityhealth.org
Facility Information:
Facility Name
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Hill
Phone
602-406-7034
Email
nicole.hill2@dignityhealth.org
First Name & Middle Initial & Last Name & Degree
Andrew Little, MD
First Name & Middle Initial & Last Name & Degree
Griffith Santarelli, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Allison
Phone
216-444-6459
Email
ALLISOT@ccf.or
First Name & Middle Initial & Last Name & Degree
Varun Kshettry, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study is IRB approved to share deidentified data outside of the institution, with presence of a valid data sharing agreement.

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Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

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