Risk Factors for Early POCD(Postoperative Cognitive Dysfunction) in the Patients With PSM(Peritoneal Surface Malignancies )Undergoing CRS(Cytoreductive Surgery) and HIPEC(Hyperthermic Intraperitoneal Chemo-therapy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy
研究概览
简要总结
Objectives to investigate the incidence and associated factors for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods fifty patients aged 18-65 yr were included in the research and were grouped base on the score of neuropsychological assessments which had done in the ward at 7 day before and after the surgery. The investigators monitored various indicators in the perioperative period, such as age, body weight, sex, education, duration of operation, intraoperative blood loss, cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at the various stage of the operation and 24 hours after the operation, and the differences of data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age < 65 years or >18 years
- •The patients with peritoneal surface malignancies willing to undergo the cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
排除标准
- •age < 18 years or >65 years
- •several organ function severely abnormal and can not tolerate the surgery,such as suffering from severely anemia, liver and renal function disfunction, heart and cerebrovascular disease
- •cognitive function was assessed by Mini-Mental State Examination (MMSE) at 1 day before operation and the score<23
- •people with neurological and psychiatric disease, such as anxiety, senile dementia, stroke sequela, cerebral hemorrhage, etc
- •psychiatric drug abusers
- •patients reluctant to go along with the trial
结局指标
主要结局
Incidence for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy
时间窗: 12 months
次要结局
- Risk factor for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(12 months)
研究者
Mian Peng
Doctor
Wuhan University