[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489930":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":73,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":18,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":18,"overallStatus":36,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"St. Joseph's Hospital and Medical Center, Phoenix","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nasal saline irrigation","ACTIVE_COMPARATOR","Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations",[13],"Other: Nasal saline irrigation",{"label":15,"type":16,"description":17,"interventionNames":18},"No Intervention","NO_INTERVENTION","Patients randomized to not performing saline sinonasal irrigations.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"The following nasal care recommendations have been approved by the study protocol committee for patients randomized to the treatment arm with saline irrigations:\n\n* Postoperative days 1 through 3: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily.\n* 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.",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Val Calores","CONTACT","602-406-8772","Val.calores@dignityhealth.org",{"name":30,"role":26,"phone":31,"phoneExt":18,"email":32},"Malika Bhargava","602-406-7121","Malika.Bhargava@dignityhealth.org",[34,56],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Barrow Neurological Institute at St. Joseph's Hospital and Medical Center","RECRUITING","Phoenix","Arizona","85013","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-112.07404,33.44838,{"lat":46,"lon":45},[49,50,53],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},{"name":51,"role":52,"phone":18,"phoneExt":18,"email":18},"Andrew Little, MD","PRINCIPAL_INVESTIGATOR",{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Griffith Santarelli, MD","SUB_INVESTIGATOR",{"facility":57,"status":36,"city":58,"state":59,"zip":60,"country":40,"countryCode":41,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":43,"coordinates":62},[63,64],-81.69541,41.4995,{"lat":64,"lon":63},[67,71],{"name":68,"role":26,"phone":69,"phoneExt":18,"email":70},"Teresa Allison","216-444-6459","ALLISOT@ccf.or",{"name":72,"role":52,"phone":18,"phoneExt":18,"email":18},"Varun Kshettry, MD",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Lori Wood","Operations Manager of Neurosurgery Research",[78],{"name":79,"class":80},"Barrow Brain and Spine","UNKNOWN","100489930","nasal-outcomes-using-saline-irrigations-after-endonasal-pituitary-surgery-100489930",false,"NCT05659524","Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery","Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial","NOSE","Inclusion criteria\n\n1. Adult patient undergoing endoscopic surgery for resection of pituitary tumors\n\n   * nonfunctioning adenoma\n   * acromegaly\n   * prolactinoma\n   * Rathke's cleft cyst\n2. Adults \\>18 and \\\u003C85 years of age\n3. English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales\n4. Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable\n5. Planned binostril surgical approach\n6. Either with or without septal flap reconstruction\n7. Either with or without septoplasty\n\nExclusion criteria\n\n1. Active sinus infection\n2. Allergic rhinitis\n3. Asthma\n4. Vascular or inflammatory disease\n5. History of previous sinonasal surgery\n6. Any subject who is unwilling or unable to sign informed consent for the study\n7. Pregnancy\n8. Incarcerated patients\n9. Cushing's disease\n10. History of chronic sinusitis\n11. Extended approaches to the skull base\n12. Active sinusitis\n13. Nasal polyps\n14. Concurrent antibiotics for another indication (i.e., urinary tract infection)\n15. Immunodeficiency\n16. History of radiation to the skull base","ALL","19 Years","85 Years",{"count":93,"type":94},140,"ESTIMATED","INTERVENTIONAL",[97],"NA","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.",[100],"Pituitary Tumor","2024-04-17",{"date":103,"type":104},"2024-04-19","ACTUAL",{"date":106,"type":104},"2020-12-18",{"date":108,"type":94},"2029-12-31",{"name":75,"class":6},2]