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临床试验/NCT01049607
NCT01049607已完成3 期

Clamp-Crushing vs. Stapler Hepatectomy for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH - A Randomized Controlled Trial

Nuh Rahbari2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
130
试验地点
2
主要终点
Intraoperative blood loss

研究概览

简要总结

There is clinical uncertainty and ongoing discussion among liver surgeons regarding the optimal method of parenchymal transection in patients undergoing elective hepatic resection. While the clamp-crushing technique still represents the reference technique for routine liver resections, transection of liver parenchyma using vascular staplers may offer a new and safe technique potentially reducing intraoperative blood loss, operation time as well as peri-operative morbidity. As morbidity of patients undergoing hepatic resection remains high, approaches to lower peri-operative complications are urgently required. Due to the lack of evidence it has to be evaluated, if the technique of stapler hepatectomy decreases intraoperative blood loss as a highly relevant predictor of peri-operative complications, patients' hospital stay and finally health care expenditures. These advantages would favor stapler hepatectomy to be applied in routine liver resections. As RCTs are generally considered to generate the most valid scientific evidence on a treatment's effects, the present trial evaluates potential benefits of stapler hepatectomy in a randomized fashion.

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
Double (Participant, Outcomes Assessor)

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

  • Patients scheduled for elective hepatic resection
  • Stapler hepatectomy and clamp-crushing feasible based on preoperative imaging
  • Age equal or greater than 18 years
  • Informed consent

排除标准

  • Participation in concurrent intervention trials
  • Expected lack of compliance
  • Impaired mental state or language problems

结局指标

主要结局

Intraoperative blood loss

时间窗: 2.5 hours

次要结局

未报告次要终点

研究者

发起方
Nuh Rahbari
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nuh Rahbari

M.D. Resident

Heidelberg University

研究点 (2)

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