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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05659524
Other study ID # PHX-20-500-189-30-12
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 18, 2020
Est. completion date December 31, 2029

Study information

Verified date April 2024
Source St. Joseph's Hospital and Medical Center, Phoenix
Contact Val Calores
Phone 602-406-8772
Email Val.calores@dignityhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 31, 2029
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group 19 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio
United States Barrow Neurological Institute at St. Joseph's Hospital and Medical Center Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Lori Wood Barrow Brain and Spine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in mean sinonasal quality of life Difference in mean sinonasal quality of life between groups as determined by patient reported Sino-nasal Outcome Test (SNOT-22) scores at 4 weeks. SNOT-22 scoring can be completed during a clinic visit or by phone interview. It is critical that the follow-up times are standardized because symptoms improve with time. A reduction in SNOT-22 composite score is indicative of improvement in symptoms. 12 weeks
Secondary Endoscopy findings Postoperative nasal endoscopy findings of purulence, nasal crusting, polyps, and synechiae as estimated on the Endoscopic Appearances scale developed by Lund- Kennedy at 1 week, 4 weeks, and 12 weeks after surgery. 12 weeks
Secondary Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores Sinonasal quality of life as determined by patient-reported ASK Nasal-12 scores at
1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after surgery.
12 weeks
Secondary Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) overall scores at 1week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery. 12 weeks
Secondary Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores at 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after surgery. 12 weeks
Secondary Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction. Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction. 12 weeks
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