MedDataX Logo

Stapler vs. LigaSure in Elective Hepatic Resection

NCT ID: NCT01858987

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-02

Study Completion Date

2014-08-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Resection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stapler hepatectomy

Liver resection using vascular stapler for transection of the parenchyma

Group Type ACTIVE_COMPARATOR

Stapler hepatectomy

Intervention Type PROCEDURE

Liver resection using vascular stapler for transection of the parenchyma

vascular staple

Intervention Type OTHER

LigaSure Hepatectomy

Liver resection using LigaSure for transection of the parenchyma

Group Type EXPERIMENTAL

LigaSure hepatectomy

Intervention Type PROCEDURE

Liver resection using LigaSure for transection of the parenchyma

Ligasure

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stapler hepatectomy

Liver resection using vascular stapler for transection of the parenchyma

Intervention Type PROCEDURE

LigaSure hepatectomy

Liver resection using LigaSure for transection of the parenchyma

Intervention Type PROCEDURE

Ligasure

Intervention Type DEVICE

vascular staple

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients scheduled for elective hepatic resection
* Parenchymal transection by vascular stapler and LigaSure feasible
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria

* Extrahepatic resection required based on preoperative imaging
* Participation in concurrent surgical intervention trials
* Expected lack of compliance
* Impaired mental state or language problems
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nuh Rahbari

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UniversityHospital Dresden

Dresden, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Fritzmann J, Kirchberg J, Sturm D, Ulrich AB, Knebel P, Mehrabi A, Buchler MW, Weitz J, Reissfelder C, Rahbari NN. Randomized clinical trial of stapler hepatectomy versus LigaSure transection in elective hepatic resection. Br J Surg. 2018 Aug;105(9):1119-1127. doi: 10.1002/bjs.10902.

Reference Type DERIVED
PMID: 30069876 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NNR-08

Identifier Type: -

Identifier Source: org_study_id