The Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery ： Results of a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The incidence of postoperative pancreatic fistula and abdominal infection;
研究概览
简要总结
Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ECOG 0-2;
- •The amylase value in the drainage tube of patients receiving pancreaticoduodenectomy or distal pancreatectomy was lower than 5000 IU/L on the first day after surgery;
- •postoperative drainage tube placement;
- •Patients with no obvious contraindication to surgery;
- •Expected postoperative survival ≥3 months;
排除标准
- •Pancreaticoduodenectomy and pancreaticogastric anastomosis were performed;
- •Suspicion or abdominal bleeding within 5 days after surgery;
- •suspected biliary and intestinal fistula within 5 days after operation;
- •On the fifth day after the operation, abdominal CT reexamination showed local effusion with a depth greater than 3cm.
结局指标
主要结局
The incidence of postoperative pancreatic fistula and abdominal infection;
时间窗: 3month
Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification.
时间窗: 3month
次要结局
未报告次要终点
研究者
Xian-Jun Yu
President of Pancreatic Cancer Institute
Fudan University