Ligasure II: Standard Stapling Versus Ligasure

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01349426

Enrollment

172

Registered

2011-05-06

Start date

2010-09-30

Completion date

2015-02-28

Last updated

2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Resection

Keywords

Lung resection, Parenchymal pneumostasis, haemostasis, Fissure closure, Automatic staplers,LigaSure, Force Triad Generator, Bipolar fusion, Procedure cost

Brief summary

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.

Interventions

DEVICELigaSure Force Triad Vessel Sealing System

Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rates of post-operative air leak between the two techniques	Day 1

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026