Stapler vs. LigaSure for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH II - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Intraoperative Blood loss
研究概览
简要总结
The optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication rates. Although numerous devices have been introduced and are used widely, high-level evidence, randomized controlled trials, that evaluate efficacy and safety of these devices are scarce. In the present randomized controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and safety of both methods.
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
- 否
入选标准
- •Patients scheduled for elective hepatic resection
- •Parenchymal transection by vascular stapler and LigaSure feasible
- •Age equal or greater than 18 years
- •Informed consent
排除标准
- •Extrahepatic resection required based on preoperative imaging
- •Participation in concurrent surgical intervention trials
- •Expected lack of compliance
- •Impaired mental state or language problems
研究组 & 干预措施
Stapler hepatectomy
Liver resection using vascular stapler for transection of the parenchyma
干预措施: Stapler hepatectomy (Procedure)
Stapler hepatectomy
Liver resection using vascular stapler for transection of the parenchyma
干预措施: vascular staple (Other)
LigaSure Hepatectomy
Liver resection using LigaSure for transection of the parenchyma
干预措施: LigaSure hepatectomy (Procedure)
LigaSure Hepatectomy
Liver resection using LigaSure for transection of the parenchyma
干预措施: Ligasure (Device)
结局指标
主要结局
Intraoperative Blood loss
时间窗: Beginning to end of surgical procedure
Intraoperative blood loss represents the primary efficacy endpoint of the CRUNSH II-Trial. To obtain a more precise estimate for the individual patient patient's individual transection area will be considered as a continuous covariate in the analysis of covariance (ANOVA). The transection area will be assessed using an imprint of the resected specimen on a paper sheet with a known density of 80 mg/m2. The marked paper area will be cut and weight to calculate the transection area. Intraoperative blood loss will be measured according to the blood collected in the suction containers. Spilling water and ascites will be subtracted. Furthermore, swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers. Central venous pressure will be lowered below 5 cmH2O for the transection period.
次要结局
未报告次要终点