Clinical trial · Interventional
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
NCT05659524CI-TRIAL-00076271NOSErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nasal saline irrigation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Nasal saline irrigation
- description
- Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations
- interventionNames
- Other: Nasal saline irrigation
- type
- NO_INTERVENTION
- label
- No Intervention
- description
- Patients randomized to not performing saline sinonasal irrigations.
Primary outcomes (1)
- measure
- Difference in mean sinonasal quality of life
- timeFrame
- 12 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.