NCT01040013已完成2 期
GUT OXYGENATION DURING AND AFTER LAPAROSCOPIC AND OPEN COLON RESECTION. A RANDOMIZAD CLINICAL TRIAL
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intestinal oxygenation
研究概览
简要总结
Patients with left-colon cancer will be randomized to laparoscopic or laparotomic operation. during surgery and for 6 days after operation, intestinal oxygen tension and ischemia-reperfusion injury markers will be evaluated to understand if pneumoperitoneum is associated with reduced splanchnic blood flow and ischemia-reperfusion injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven Cleft Colon Cancer, Signed Informed Consent
排除标准
- •Emergency surgery,
- •Cancer infiltrating adjacent organ (at CT scan),
- •Severe cardiovascular (New York Heart Association class > 3 ),
- •Respiratory (arterial PO2 < 70 mmHg),
- •Renal (plasma creatinine > 3 MG/dL) or hepatic (Child C) dysfunction
结局指标
主要结局
Intestinal oxygenation
时间窗: 7 DAYS
次要结局
- Ischemic reperfusion injury(7 DAYS)
研究者
研究点 (2)
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