Nasal saline rinses after pituitary tumor surgery through the nose
Tests nasal saline rinses after nose-route surgery for pituitary tumor.
Key facts
- Who runs it
- Lori Wood
- Where
- Cleveland and Phoenix, United StatesSee the 2 sites
- Trial code
- Registry title
- Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
- Status
- Recruiting
- People taking part
- 140 people, planned
- Started
- 18 Dec 2020
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Nasal saline irrigation
- Record updated
- 19 April 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults having endoscopic surgery through the nose to remove a pituitary tumor. It tests whether rinsing the nose with salt water after surgery helps.
- Age
- Adults >18 and <85 years (record lists 19 Years to 85 Years).
- Sex
- All sexes can join.
- Disease stage
- Pituitary tumors: nonfunctioning adenoma, acromegaly, prolactinoma, or Rathke's cleft cyst. Surgery planned through both nostrils, with or without septal flap repair or septoplasty.
- Earlier treatment
- People who had nose or sinus surgery before, or radiation to the skull base, cannot join.
Main reasons for not taking part
- Active sinus infection, chronic sinusitis, nasal polyps, allergic rhinitis or asthma
- Cushing's disease or extended surgery to the skull base
- Vascular or inflammatory disease, or a weak immune system
- Pregnancy, or being in prison
- Taking antibiotics for another reason, such as a urinary tract infection
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of previous sinonasal surgery
- Concurrent antibiotics for another indication (i.e., urinary tract infection)
- Active sinus infection
- Allergic rhinitis
- Vascular or inflammatory disease
- Cushing's disease
- History of chronic sinusitis
- History of radiation to the skull base
- Asthma
- Any subject who is unwilling or unable to sign informed consent for the study
- Pregnancy
- Incarcerated patients
- Extended approaches to the skull base
- Active sinusitis
- Nasal polyps
- Immunodeficiency
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 85 years old?
Where in United States
- Cleveland ClinicCleveland, United StatesContact: Teresa AllisonTaking people
- Barrow Neurological Institute at St. Joseph's Hospital and Medical CenterPhoenix, United StatesContact: Val CaloresTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Nasal saline irrigationExisting treatment, for comparison
Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations
- No InterventionNo study treatment, for comparison
Patients randomized to not performing saline sinonasal irrigations.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
- Plain-language title
- Nasal saline rinses after pituitary tumor surgery through the noseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT05659524, who can take part
- Record updated
- 19 April 2024