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

NCT ID: NCT05659524Sponsor: Lori WoodLast updated: 2024-04-19

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.

Arms & interventions

  • OtherNasal 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.

Outcome measures

Primary

  • 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.

    Time frame: 12 weeks

Secondary

  • 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

Sex: AllAge: 19 Years to 85 YearsHealthy volunteers: No
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 locations (2)

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

Recruiting
Val Calores · Contact
602-406-8772Val.calores@dignityhealth.org
Andrew Little, MD · Principal Investigator
Griffith Santarelli, MD · Sub Investigator

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting
Teresa Allison · Contact
216-444-6459ALLISOT@ccf.or
Varun Kshettry, MD · Principal Investigator
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery | Cancerify