Recruiting

Saline Irrigation

Sponsor:

Lori Wood

Code:

NCT05659524

Conditions

Pituitary Tumor

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Nasal saline irrigation

Study Details

Brief 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.

Conditions

Pituitary Tumor

Study ID

NCT05659524

Start date

Dec 18, 2020

Status verified date

Apr, 2024

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Val Calores

602-406-8772Val.calores@dignityhealth.org

Malika Bhargava

602-406-7121Malika.Bhargava@dignityhealth.org

Locations

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

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Val Calores

602-406-8772Val.calores@dignityhealth.org

Principal Investigator:

Andrew Little, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Teresa Allison

216-444-6459ALLISOT@ccf.or

Principal Investigator:

Varun Kshettry, MD

More Information

Sponsor

Lori Wood

Last update posted

Apr 19, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lori Wood on 2024-04-19.