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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 85
Healthy Volunteers: f
View:

• Adult patient undergoing endoscopic surgery for resection of pituitary tumors

‣ nonfunctioning adenoma

⁃ acromegaly

⁃ prolactinoma

⁃ Rathke's cleft cyst

• Adults \>18 and \<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, in the opinion of the investigator, makes study participation inadvisable

• Planned binostril surgical approach

• Either with or without septal flap reconstruction

• Either with or without septoplasty

Locations
United States
Arizona
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
RECRUITING
Phoenix
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Val Calores
Val.calores@dignityhealth.org
602-406-8772
Backup
Malika Bhargava
Malika.Bhargava@dignityhealth.org
602-406-7121
Time Frame
Start Date: 2020-12-18
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 140
Treatments
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.
Sponsors
Collaborators: Barrow Brain and Spine
Leads: Lori Wood

This content was sourced from clinicaltrials.gov