Actively Recruiting
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
Led by Lori Wood · Updated on 2024-04-19
140
Participants Needed
2
Research Sites
471 weeks
Total Duration
On this page
Sponsors
L
Lori Wood
Lead Sponsor
B
Barrow Brain and Spine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient undergoing endoscopic surgery for resection of pituitary tumors including nonfunctioning adenoma, acromegaly, prolactinoma, or Rathke's cleft cyst
- Adults older than 18 and younger than 85 years of age
- English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales
- Free of any physical, mental, or medical condition which makes study participation inadvisable as determined by the investigator
- Planned binostril surgical approach
- Either with or without septal flap reconstruction
- Either with or without septoplasty
You will not qualify if you...
- Active sinus infection
- Allergic rhinitis
- Asthma
- Vascular or inflammatory disease
- History of previous sinonasal surgery
- Unwilling or unable to sign informed consent
- Pregnancy
- Incarcerated patients
- Cushing's disease
- History of chronic sinusitis
- Extended approaches to the skull base
- Active sinusitis
- Nasal polyps
- Concurrent antibiotics for other indications
- Immunodeficiency
- History of radiation to the skull base
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
V
Val Calores
CONTACT
M
Malika Bhargava
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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