A Comparative Study Assessing Improvement in Cognitive Deficit Secondary to CRS in Patients Treated With Medical Vs Surgical Management: A Prospective Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Modified mini mental state examination
研究概览
简要总结
Chronic rhinosinusitis presents with a plethora of symptoms including non-rhinologic symptoms such as depression, sleep disturbances & the more recently recognized cognitive dysfunction. It has recently been identified that sinus specific treatments such as endoscopic sinus surgery can improve cognitive outcomes in patients with cognitive deficit secondary to chronic inflammation in the upper and lower airway. However, it remains to be seen whether or not offering surgery to these patients at an earlier date has an impact on the degree of improvement on cognitive function in comparison to patients who have to wait long periods for their treatment.
详细描述
Purpose To compare the improvement in cognitive deficit after medical management and surgical management in the treatment of Chronic Rhinosinusitis.
Hypothesis Cognitive deficit secondary to chronic rhinosinusitis will show a greater improvement with surgical management when compared to medical management.
Cognitive deficit secondary to chronic rhinosinusitis will improve quicker postoperatively for patients offered endoscopic sinus surgery earlier than for those who are placed on long waitlists for surgery
Study Design:
This is a prospective cohort series to be conducted at the St. Paul's Sinus Centre. All patients recruited into the study would have been diagnosed with chronic rhinosinusitis and will be subjected to appropriate and standardized medical management. They will be subjected to surgical management if they are not completely relieved of their symptoms. Prior to medical or surgical management, they will be subjected to the modified mini mental state examination to assess their baseline and post treatment (medical and surgical) cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with CRS (with/without polyps) and are willing to undergo medical management with antibiotics or steroids, and/or surgical management with functional endoscopic sinus surgery if required
排除标准
- •Patients currently having sinonasal tumors - as the middle turbinate may have to be resected in certain cases
- •Has undergone functional endoscopic sinus surgery
- •Patients with autoimmune diseases affecting the upper airway (e.g. systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, etc.)
- •Are immuno-compromised, and have impairment in mucociliary function (e.g. cystic fibrosis, Kartagener syndrome)
研究组 & 干预措施
Medical Management and Sinus Surgery in private system
These patients will first receive medical management for their symptoms and then will undergo sinus surgery much earlier than the other group as they will include patients being operated in the private system.
干预措施: Private system endoscopic sinus surgery (Procedure)
Medical Management and Sinus Surgery in public system
These patients will first receive medical management for their symptoms, and then will undergo sinus surgery after a waiting period of at least 1 year since they are on the public wait-list.
干预措施: Public system endoscopic sinus surgery (Procedure)
Medical Management Only
These patients will only receive medical management for their symptoms as they will not require sinus surgery.
干预措施: Budesonide (Drug)
结局指标
主要结局
Change in Modified mini mental state examination
时间窗: Before starting medical or surgical management and then 6 months after
This short test consists of questions to assess memory which will take 5-10 minutes to complete.
次要结局
- Change in Cognitive failures Questionnaire(Before starting medical or surgical management and then 6 months after)
- Change in Sino-nasal Outcome Test-22 (SNOT-22) scores:(Before starting medical or surgical management and then 6 months after)
- Change in Nasal endoscopy(Before starting medical or surgical management and then 6 months after)
研究者
Amin Javer
Clinical Professor
St. Paul's Hospital, Canada