Cognitive Changes After Surgery in the Elderly: Does Minimally Invasive Surgery Influence the Incidence of Postoperative Cognitive Changes Compared to Open Colon Surgery?
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Confusion
研究概览
简要总结
A study will be conducted to determine if there is any cognitive benefit in elderly patients having open versus minimally invasive colon cancer surgery.
详细描述
Cognitive changes in the elderly are common after surgery. It is not known if minimally invasive or laparoscopic surgery can prevent these changes. A study will be conducted on patients scheduled to have abdominal surgery. The patients will have cognitive evaluations before and after surgery. A small amount of blood, about 2 tablespoons, will be collected no more than 5 times in 6 months. The results will be analyzed to determine if there are changes between those having open surgery versus patients having laparoscopic or minimally invasive surgery, and if these changes coincide with cognitive changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over age 65.0 years and in need of elective colon resection for adenocarcinoma
排除标准
- •Inability to complete preoperative cognitive screening
- •Inability to complete study in English since CANTAB is timed and not validated with interpreters
- •Emergency surgery
- •Depression or psychiatric comorbidity
- •Pre-existing dementia
- •Previous cerebrovascular accident or "stroke"
- •Previous myocardial infarction
- •Cardiac ejection fraction below 55%
- •Propranolol, metoprolol or other betablocker use
- •Digoxin, procainamide, or amiodarone use
- •Calcium channel blocker use
- •History of vascular surgery or arterial vascular disease
- •History of alcohol dependence
- •Lovastatin or other HMG-CoA reductase inhibitor use
- •Ace inhibitor use
- •Neuroendocrine or catecholamine associated tumors
- •Hypertension
- •Benzodiazepine use
- •Dimenhydrinate or other medications to treat motion sickness
- •Metaclopramide use
结局指标
主要结局
Confusion
时间窗: 6 Months
Confusion assessed by questionaires and cognitive testing
次要结局
- nutritional status(6 months)
- degree of inflammation(6 Months)
- pituitary-thyroid axis disruption(6 months)
- presence of electrolyte imbalance(6 months)
- liver function tests(6 months)
研究者
Mitchell Chorost
Principal Investigator
New York Hospital Queens