Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05659524
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Lori Wood
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Tumor

Additional Details

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

Arms

Active Comparator: Nasal saline irrigation

Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations

No Intervention: No Intervention

Patients randomized to not performing saline sinonasal irrigations.

Interventions

Other: - Nasal 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

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

Phoenix, Arizona, 85013

Site Contact

Val Calores

[email protected]

602-406-8772

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Teresa Allison

[email protected]

216-444-6459

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