Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage Ore Other Complications
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio
研究概览
简要总结
Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms.
详细描述
Patients undergoing LAR for rectum cancer is subjected to peritoneal microdialyses during the postoperative period until the 7. postoperative day. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient. Before removing the microdialysis catheter a CT whit rectal enema is preformed. Every day the patient will be evaluated whit a standardised clinical scoring system with attention at anastomotic leakage.
A total of 150 patients will be included in this study. The results of the peritoneal microdialyses will be compared with the clinical scorings system in each patient. The results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. This will be compared to results from patients with various complications.
The study is approved by the local scientific ethical committee No. ------
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological verified cancer
- •The cancer must be located in rectum maximum of 15 cm.
- •Diverting stoma is allowed
- •Perioperative radio-chemotherapy is allowed
排除标准
- •Disseminated cancer
结局指标
主要结局
Significant elevated peritoneal microdialysis parameter like lactate and L/P-ratio
时间窗: Clinically complications with in 30th days after surgery
次要结局
未报告次要终点
研究者
Mark Ellebaek Pedersen
Doctor
Odense University Hospital