NCT01858987

Stapler vs. LigaSure in Elective Hepatic Resection

Stapler vs. LigaSure for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH II - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Liver Resection

Interventions

Type	Name	Description
PROCEDURE	Stapler hepatectomy	Liver resection using vascular stapler for transection of the parenchyma
PROCEDURE	LigaSure hepatectomy	Liver resection using LigaSure for transection of the parenchyma
DEVICE	Ligasure
OTHER	vascular staple

Timeline

• Start date: 2011-11-02
• Primary completion: 2014-07-17
• Completion: 2014-08-14
• First posted: 2013-05-21
• Last updated: 2017-10-09

Locations

1 site across 1 country: Germany