Decompressive Laparotomy With Temporary Abdominal Closure Versus Percutaneous Puncture With Placement of Abdominal Catheter in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis:Multicenter, Randomised, Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.
研究概览
简要总结
Decompressive laparotomy with temporary abdominal closure, will decrease of overall mortality and major morbidity in patients with abdominal compartment syndrome during acute pancreatitis in comparison with percutaneous puncture with placement of abdominal catheter.
详细描述
We anticipated that decompressive laparotomy with temporary abdominal closure, beside all potentially negative side effects that early open surgery carries in patients with acute pancreatitis, results in decrease of overall mortality and major morbidity. The DECOMPRESS study is designed to compare effects of decompressive laparotomy with temporary abdominal closure and percutaneous puncture with placement of abdominal catheter in patients with abdominal compartment syndrome during acute pancreatitis.
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
- •The study population consists of patients with acute pancreatitis complicated with development of abdominal compartment syndrome.
排除标准
- •Patients will not be enrolled to the study if any of the following criteria will be present:
- •age < 18 and > 80 years
- •recent surgical interventions
- •psychoses
- •pregnancy
- •previously history of chronic pancreatitis
研究组 & 干预措施
1
Decompressive laparotomy with temporary abdominal closure
干预措施: Decompressive laparotomy with temporary abdominal closure (Procedure)
2
Patients who will receive percutaneous puncture with placement of abdominal catheter
干预措施: Percutaneous puncture with placement of abdominal catheter (Procedure)
结局指标
主要结局
Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.
时间窗: 2 years
次要结局
- duration time of organ failure(2 years)
- development of a new organ failure(2 years)
- number of infectious complications,(2 years)
- needs for necrosectomy,(2 years)
- intensive care stay(2 years)
- total hospital stay(2 years)