Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery
NCT ID: NCT05659524
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2020-12-18
2029-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Nasal saline irrigation
Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations
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.
No Intervention
Patients randomized to not performing saline sinonasal irrigations.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
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
19 Years
85 Years
ALL
No
Sponsors
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Barrow Brain and Spine
UNKNOWN
Lori Wood
OTHER
Responsible Party
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Lori Wood
Operations Manager of Neurosurgery Research
Locations
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Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PHX-20-500-189-30-12
Identifier Type: -
Identifier Source: org_study_id
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