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Recruiting
NCT05659524
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
Conditions: Pituitary Tumor
Sex: All
Ages: 19 Years – 85 Years
Phase: NA
Enrollment: 140
Sponsor: Nicole Hill
Location: United States
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.
Eligibility Criteria
Inclusion criteriaAdult patient undergoing endoscopic surgery for resection of pituitary tumorsnonfunctioning adenomaacromegalyprolactinomaRathke's cleft cystAdults >18 and <85 years of ageEnglish speaking and able to understand the ASK Nasal-12 and SNOT-22 scalesFree of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisablePlanned binostril surgical approachEither with or without septal flap reconstructionEither with or without septoplastyExclusion criteriaActive sinus infectionAllergic rhinitisAsthmaVascular or inflammatory diseaseHistory of previous sinonasal surgeryAny subject who is unwilling or unable to sign informed consent for the studyPregnancyIncarcerated patientsCushing's diseaseHistory of chronic sinusitisExtended approaches to the skull baseActive sinusitisNasal polypsConcurrent antibiotics for another indication (i.e., urinary tract infection)ImmunodeficiencyHistory of radiation to the skull base
Source: ClinicalTrials.gov (NCT05659524). StuddyBuddy aggregates publicly available trial information.