Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
研究概览
简要总结
Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage
详细描述
The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. These parameters are: Patient general condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive protein), white blood cells, blood gases.The patients are their own controls when the purpose is to see if you can detect early complications with Onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. The patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of Onzurf probe. No interventions will be carried out on the patient.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department
排除标准
- •Surgical recontruction other than Gastric Tube
结局指标
主要结局
Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
时间窗: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
次要结局
未报告次要终点