RecruitingNot ApplicableNCT05659524

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial


Sponsor

Lori Wood

Enrollment

140 participants

Start Date

Dec 18, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how well saline (saltwater) nasal rinses help people recover after surgery to remove a pituitary tumor through the nose. Researchers want to find out if rinsing with saline improves nasal comfort and outcomes after this type of surgery. **You may be eligible if...** - You are an adult (18–85 years old) having endoscopic surgery through the nose to remove a pituitary tumor (including non-functioning adenoma, acromegaly, prolactinoma, or Rathke's cleft cyst) - You speak English and can complete standard nasal symptom questionnaires - The surgery is planned through both nostrils **You may NOT be eligible if...** - You have an active sinus infection, allergic rhinitis, or asthma - You have a history of previous sinus or nasal surgery - You have nasal polyps, chronic sinusitis, or a history of radiation to the skull base - You have an immune deficiency - You are pregnant or incarcerated - You are currently taking antibiotics for an unrelated condition - You have Cushing's disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNasal 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.


Locations(2)

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

Phoenix, Arizona, United States

Cleveland Clinic

Cleveland, Ohio, United States

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NCT05659524


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