Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pituitary Tumor

Intervention / Treatment
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* Other: Nasal saline irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal saline irrigation<br>Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations | Other: Nasal saline irrigation<br>* 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.<br>|
| No Intervention: No Intervention<br>Patients randomized to not performing saline sinonasal irrigations. | |

What is the study measuring?
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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 |