Clinical trial NCT05659524: Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
Official title: Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pituitary Tumor
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Barrow Brain and Spine
First posted: 2022-12-21
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in mean sinonasal quality of life
timeFrame: 12 weeks
Secondary outcomes:
measure: Endoscopy findings
timeFrame: 12 weeks
measure: Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores
timeFrame: 12 weeks
measure: Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22)
timeFrame: 12 weeks
measure: Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores
timeFrame: 12 weeks
measure: Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
state: Arizona
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References: