Ligasure II: Standard Stapling Versus Ligasure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lung Resection

Intervention / Treatment
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* Device: LigaSure Force Triad Vessel Sealing System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LigaSure<br>Arm 1 Patients undergoing lung surgery | Device: LigaSure Force Triad Vessel Sealing System<br>* Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers<br>* Other names: Endo GIA II MULTIFIRE;|
| Active Comparator: Automatic Staplers<br>Arm 2 Patients undergoing lung surgery | Device: LigaSure Force Triad Vessel Sealing System<br>* Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers<br>* Other names: Endo GIA II MULTIFIRE;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung resection, Parenchymal pneumostasis, haemostasis, Fissure closure, Automatic staplers,LigaSure, Force Triad Generator, Bipolar fusion, Procedure cost