Ligasure II: Standard Stapling Versus Ligasure

July 27, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial

Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital
      • Clermont Ferrand, France
        • CHU Clermont Ferrand - Service of Thoracic Surgery
      • Grenoble, France
        • CHU Grenoble - Department of Vascular and Thoracic Surgery
      • Lille, France
        • CHU Lille - Service of Thoracic Surgery
      • Limoges, France
        • Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery
      • Marseille, France
        • CHU Marseille - Department of Thoracic Surgery
      • Nice, France
        • CHU Nice - Pasteur Hospital - Department of Thoracic Surgery
      • Saint-etienne, France, 42100
        • CHU Saint-Etienne
      • Strasbourg, France
        • CHU Strasbourg - Service of Thoracic Surgery
      • Toulouse, France
        • Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18 years
  • Patients scheduled for thoracotomy, lobectomy or bilobectomy
  • Patients must give informed consent

Exclusion Criteria:

  • Patient is unwilling or unable to provide informed consent
  • Patients who can not tolerate thoracotomy
  • Patients who require extensive dissection to release adhesions which may result in air leak and/or bleeding unrelated to the quality of the parenchymal seal achieved by the devices in question
  • Patients with no parenchymal bridge between lobes; 100% complete fissure.
  • Patients with complete incomplete fissure with a thickness > 1.5 cm measure intraoperatively

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LigaSure
  • Arm 1
  • Patients undergoing lung surgery
Device: LigaSure Force Triad Vessel Sealing System
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
Other Names:
  • Automatic Staplers TA30P, TA55
  • Endo GIA II MULTIFIRE
Active Comparator: Automatic Staplers
  • Arm 2
  • Patients undergoing lung surgery
Device: LigaSure Force Triad Vessel Sealing System
Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
Other Names:
  • Automatic Staplers TA30P, TA55
  • Endo GIA II MULTIFIRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rates of post-operative air leak between the two techniques
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the number of lung stitches between LigaSure device and standard staplers
Time Frame: Day 1
Day 1
Evaluate the cost of LigaSure vs standard staplers in similar procedures including the cost of each instrument and the staple loads fired.
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: TIFFET Olivier, MD, CHU Sainte-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1008067
  • 2010-A00666-33 (Other Identifier: AFSSAPS registration)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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