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Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

RecruitingNAAges 19 Years - 85 YearsAllLori Wood
NCT05659524 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Nasal saline irrigation
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Where

2 sites
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, United States
Cleveland Clinic
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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