Nasal Outcomes Using Saline Irrigations After Endonasal Pituitary Surgery - The NOSE Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Difference in mean sinonasal quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Active sinus infection
- •Allergic rhinitis
- •Vascular or inflammatory disease
- •History of previous sinonasal surgery
- •Any subject who is unwilling or unable to sign informed consent for the study
- •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
结局指标
主要结局
Difference in mean sinonasal quality of life
时间窗: 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.
次要结局
- Sinonasal quality of life as determined by patient-reported Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12) scores(12 weeks)
- Sinonasal quality of life as determined by Sinonasal Outcomes Test 22 (SNOT-22)(12 weeks)
- Endoscopy findings(12 weeks)
- Sinonasal quality of life as determined by SNOT-22 rhinological subscale scores(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.(12 weeks)
研究者
Lori Wood
Operations Manager of Neurosurgery Research
St. Joseph's Hospital and Medical Center, Phoenix