Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Lori Wood
Study ID
NCT05659524
Status
Recruiting
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Conditions

  • Pituitary Tumor

Eligibility Criteria

Sex
ALL
Age
19 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Nasal saline irrigation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Dec 18, 2020
Status verified
Apr 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Difference in mean sinonasal quality of life [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Barrow Neurological Institute at St. Joseph's Hospital and Medical CenterPhoenixArizona85013
Val Calores
[email protected]
602-406-8772
Andrew Little, MD (PRINCIPAL_INVESTIGATOR)
Griffith Santarelli, MD (SUB_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Teresa Allison
[email protected]
216-444-6459
Varun Kshettry, MD (PRINCIPAL_INVESTIGATOR)

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Barrow Neurological Institute at St. Joseph's Hospital and Medical Center· Phoenix, AZCleveland Clinic· Cleveland, OH

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