Pituitary TumorNOSENCT05659524
Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
A study testing Nasal saline irrigation in people with Pituitary Tumor, run by Lori Wood at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pituitary Tumor
- What is being tested?
- Nasal saline irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2020to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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 join
- Active sinus infection
- Allergic rhinitis
- Asthma
- Vascular or inflammatory disease
- History of previous sinonasal surgery
- Any subject who is unwilling or unable to sign informed consent for the study
Show all 16Show fewer
- Pregnancy
- Incarcerated patients
- Cushing's disease
- History of chronic sinusitis
- Extended approaches to the skull base
- Active sinusitis
- Nasal polyps
- Concurrent antibiotics for another indication (i.e., urinary tract infection)
- Immunodeficiency
- History of radiation to the skull base
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Teresa Allison, 216-444-6459, ALLISOT@ccf.or
Varun Kshettry, MD
- Recruiting
Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Val Calores, 602-406-8772, Val.calores@dignityhealth.org
Andrew Little, MD
About this study
Official title: Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
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.
Read the detailed 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.
- Conditions
- Pituitary Tumor
- Being tested
- Nasal saline irrigation
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal saline irrigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nasal saline irrigation | Active comparator | Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations Receives: Other: Nasal saline irrigation |
| No Intervention | No intervention | Patients randomized to not performing saline sinonasal irrigations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start18 Dec 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter randomized single-blinded, intervention trial involving 70 patients from this site (140 treated patients total from all sites), undergoing endoscopic transsphenoidal surgery for pituitary lesions. The same cohort will simultaneously be used to evaluate the role of sinonasal irrigations in those patients who undergo nasoseptal flap reconstructive procedures as part of their treatment.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lori Wood
- Sponsor type
- University, hospital or other
- Collaborators
- Barrow Brain and Spine
- Responsible party
- Sponsor-investigator, Lori Wood, St. Joseph's Hospital and Medical Center, Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659524
- Sponsor's protocol ID
- PHX-20-500-189-30-12
- Acronym
- NOSE
- Status last verified
- Apr 2024
- First submitted
- 29 Nov 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study is IRB approved to share deidentified data outside of the institution, with presence of a valid data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
- ClinicalTrials.gov ID
- NCT05659524
- Acronym / sponsor ID
- NOSE / PHX-20-500-189-30-12
- Conditions
- Pituitary Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Lori WoodUniversity, hospital or other
- Collaborators
- Barrow Brain and Spine
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Multicenter randomized single-blinded, intervention trial involving 70 patients from this site (140 treated patients total from all sites), undergoing endoscopic transsphenoidal surgery for pituitary lesions. The same cohort will simultaneously be used to evaluate the role of sinonasal irrigations in those patients who undergo nasoseptal flap reconstructive procedures as part of their treatment.
| Arm | Type | Receives |
|---|---|---|
| Nasal saline irrigation | Active comparator | Other: Nasal saline irrigationPatients 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. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult patient undergoing endoscopic surgery for resection of pituitary tumors
- 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
Key exclusion criteria (16 listed)
- Active sinus infection
- Allergic rhinitis
- Asthma
- Vascular or inflammatory disease
- History of previous sinonasal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal saline irrigationThe 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. | Other | Nasal saline irrigation |
Primary outcome
Difference in mean sinonasal quality of life
Time frame: 12 weeks
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.
5 secondary outcomes
Endoscopy findings
Time frame: 12 weeks
Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores
Time frame: 12 weeks
Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22)
Time frame: 12 weeks
Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores
Time frame: 12 weeks
Sinonasal quality of life, as determined by Sinonasal Outcomes Test 22 (SNOT-22), of subgroups including septal flap reconstruction and no septal flap reconstruction.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No. Study is IRB approved to share deidentified data outside of the institution, with presence of a valid data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal saline irrigation in people with Pituitary Tumor, run by Lori Wood at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Val Calores (602-406-8772, Val.calores@dignityhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean sinonasal quality of life (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.