Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Official title

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

Overview

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.

Interventions

• 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 i

Primary outcome measures

• Difference in mean sinonasal quality of life [Time frame: 12 weeks]

Secondary outcome measures (5)

• Endoscopy findings [Time frame: 12 weeks]
• Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores [Time frame: 12 weeks]
• Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) [Time frame: 12 weeks]
• Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores [Time frame: 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. [Time frame: 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix
• Cleveland Clinic — Cleveland

Identifiers

NCT: NCT05659524 · PHX-20-500-189-30-12

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗