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Stapler vs. LigaSure in Elective Hepatic Resection

NCT01858987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2017-10-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-02
Primary Completion
2014-07-17
Completion
2014-08-14

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858987 on ClinicalTrials.gov