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临床试验/NCT02853981
NCT02853981已完成2 期

Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
72
试验地点
2
主要终点
blood loss during hepatectomy

研究概览

简要总结

The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Liver right lobe donors

排除标准

  • 未提供

研究组 & 干预措施

Harmonic scalpel group

Active Comparator

group of donors whom will undergo liver transection using harmonic scalpel.

干预措施: Harmonic scalpel (Device)

clamp-crush group

Active Comparator

group of donors whom will undergo liver transection using Kelly clamp.

干预措施: Kelly clamp crush technique (Device)

结局指标

主要结局

blood loss during hepatectomy

时间窗: intraoperative

bleeding during transection phase will be calculated in mL. based on the blood in the sucker machine and the surgical towels

次要结局

  • liver pathology from the cut margin(intraoperative)
  • transection speed(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmad Mohammad Ahmad Sultan

Assistant professor of general surgery

Mansoura University

研究点 (2)

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