Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- anastomotic leakage
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 develops.
详细描述
Patients undergoing LAR for recto-sigmoid cancer is subjected to peritoneal microdialyses during the postoperative period until discharge. Subcutaneous microdialysis serve as control. 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.
Patients undergoing abdomino-perineal rectal resection will serve as a control group.
A total of 50 patients will be included in this pilot study. The results of the peritoneal microdialyses will be compared with the clinical course 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
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 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 or the sigmoid colon
- •Diverting stoma is allowed
- •Perioperative radio-chemotherapy is allowed
排除标准
- •Disseminated cancer
- •ASA-group 4 ore higher
结局指标
主要结局
anastomotic leakage
时间窗: within 30 days
次要结局
未报告次要终点