Evaluating nasal saline irrigations after pituitary surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-blinded, multicenter study investigates the effects of sinonasal irrigations following endoscopic pituitary surgery. The aim is to gather objective data that will inform practice-changing guidelines regarding postoperative care for patients undergoing this type of surgery. By analyzing outcomes in patients who receive nasal saline irrigations, the study seeks to enhance recovery and overall surgical results. The findings will build on previous research, including the POET study, to optimize patient management post-surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Val Calores
• Email: Val.calores@dignityhealth.org
• Phone: 602-406-8772

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.