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| Name | Class |
|---|---|
| Barrow Brain and Spine | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal saline irrigation | Active Comparator | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal saline irrigation | Other | The following nasal care recommendations have been approved by the study protocol committee for patients randomized to the treatment arm with saline irrigations:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores |
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Inclusion criteria
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
Either with or without septal flap reconstruction
Either with or without septoplasty
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Val Calores | Contact | 602-406-8772 | Val.calores@dignityhealth.org | |
| Malika Bhargava | Contact | 602-406-7121 | Malika.Bhargava@dignityhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute at St. Joseph's Hospital and Medical Center | Recruiting | Phoenix | Arizona | 85013 | United States |
Study is IRB approved to share deidentified data outside of the institution, with presence of a valid data sharing agreement.
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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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.
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The study will be blinded to the Otolaryngologist involved in the study. The research team and the patient will not be blinded. The goal of blinding the Otolaryngologist is to minimize the bias in grading the Lund Kennedy endoscopic scores which are a subjective metric interpreted in the office setting.
|
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 |
| 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 |
| 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 |
| 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 |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |