Идёт набор NCT05659524

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery

Без фазы С лечением Pituitary Tumor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Nasal saline irrigation.
Кому может быть актуально: Состояния в реестре: Pituitary Tumor. Базовые параметры: 19 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial

Обзор

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.

Подробное описание

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.

Вмешательства

Другое 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 i

Первичные конечные точки

Difference in mean sinonasal quality of life [Срок оценки: 12 weeks]

Вторичные конечные точки (5)

Endoscopy findings [Срок оценки: 12 weeks]
Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores [Срок оценки: 12 weeks]
Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22) [Срок оценки: 12 weeks]
Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores [Срок оценки: 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. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

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