跳至主要内容
临床试验/NCT02814812
NCT02814812已完成不适用

Postoperative Comput Tomography as a Predictor of Postoperative Complications After Pancreatic Surgery

CHU de Reims2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年1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
CHU de Reims
入组人数
80
试验地点
2
主要终点
detection of undiagnosed postoperative complication by CT scan

研究概览

简要总结

Pancreatectomy represents the classic approach for resectable lesions of the pancreas, duodenum and periampullary region. Due to the technical skills required, the complex anatomy and the extreme fragility of the pancreatic parenchyma, pancreatic resection is still considered to be at risk of postoperative complication mainly due to pancreatic juice leaks. Anastomotic leaks are the major cause of morbidity and in-hospital mortality due to the activation of pancreatic enzymes and the following infectious and hemorrhagic complications. Severe complications negatively affect postoperative outcomes, long-term survival, quality of life, and costs. Operative mortality traditionally has been defined as the rate within 30 days or during the initial hospitalization. But in pancreatic surgery mortality rates within 90 days after pancreatic resection are double those at 30 days. In the present study, the investigators sought to evaluate the usefulness of postoperative CT-scan on the seventh postoperative day before discharging the patients to detect undiagnosed postoperative complication.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Will be included in this study, patients:
  • Having an indication of pancreatic surgery
  • In scheduled surgery
  • Agreeing to participate in the research (ie who signed the informed consent to research participation)

排除标准

  • Will not be included in this study, patients:
  • With emergency surgery
  • Protected by law
  • Under 18 years
  • Presenting an against-indications to the scanner: documented severe allergy to contrast material, kidney failure against-showing the contrast medium injection, pregnancy, lactation and/or MRI (pacemaker, metallic intraocular foreign body)

结局指标

主要结局

detection of undiagnosed postoperative complication by CT scan

时间窗: Day 7

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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