Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Last updated: April 17, 2024
Sponsor: Lori Wood
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pituitary Disorders

Treatment

Nasal saline irrigation

Clinical Study ID

NCT05659524
PHX-20-500-189-30-12
  • Ages 19-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion criteria

  1. Adult patient undergoing endoscopic surgery for resection of pituitary tumors

  • nonfunctioning adenoma

  • acromegaly

  • prolactinoma

  • Rathke's cleft cyst

  1. Adults >18 and <85 years of age

  2. English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales

  3. Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable

  4. Planned binostril surgical approach

  5. Either with or without septal flap reconstruction

  6. 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

Total Participants: 140
Treatment Group(s): 1
Primary Treatment: Nasal saline irrigation
Phase:
Study Start date:
December 18, 2020
Estimated Completion Date:
December 31, 2029

Study Description

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.

Connect with a study center

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

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.