跳至主要内容
临床试验/NCT00931554
NCT00931554已完成不适用

Early Versus Standard Drainage Removal After Pancreatic Resections: Results of a Prospective Randomized Clinical Trial

Universita di Verona2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
2
主要终点
Abdominal Complications

研究概览

简要总结

Despite a substantial decrease in postoperative mortality, morbidity after pancreatic resections is still high, even at high-volume centers. It has been recently suggested that early removal of postoperative drainages is associated to a decreased rate of intra-abdominal complications, with particular regard to pancreatic fistula. Furthermore, our research group demonstrated that measuring amylase value in drainages (AVD) on postoperative day 1 plays a cardinal role in predicting the developement of abdominal complications, including pancreatic fistula. In particular, patients with an AVD lower than 5000 IU/L in postoperative day 1 were considered at low risk of fistula. Therefore, the investigators designed a randomized prospective trial on early (postoperative day 3) versus standard (postoperative day 5) drainages removal after pancreatic resections in patients at low risk of developing pancreatic fistula (AVD < 5000 IU/L in postoperative day 1) to test whether drainages "per se" influence postoperative complication rates and to eventually validate a fast-track policy in pancreatic resections.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergone either pancreaticoduodenectomy (reconstruction by pancreaticojejunostomy) or distal pancreatectomy with an amylase value in drains on postoperative day 1 less than 5000 IU/L

排除标准

  • Pancreaticoduodenectomy reconstructed with pancreaticogastrostomy
  • Clinical suspect of postoperative haemorrhage within 72hours after the operation
  • Clinical suspect of biliary fistula
  • Fluid collection greater than 3cm at an ultrasound carried out on postoperative day 3

结局指标

主要结局

Abdominal Complications

时间窗: 1 month

次要结局

  • In-hospital stay(1 month)
  • Pulmonary complications(1 month)
  • Hospital readmission(1 month)

研究者

发起方
Universita di Verona
申办方类型
Other

研究点 (2)

Loading locations...

相似试验