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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00666-33 | Other Identifier | AFSSAPS registration |
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diffculty to include patients
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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LigaSure | Experimental |
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| Automatic Staplers | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LigaSure Force Triad Vessel Sealing System | Device | Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers |
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of post-operative air leak between the two techniques | Day 1 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TIFFET Olivier, MD | CHU Sainte-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital | Bron | France | ||||
| CHU Clermont Ferrand - Service of Thoracic Surgery |
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| Clermont-Ferrand |
| France |
| CHU Grenoble - Department of Vascular and Thoracic Surgery | Grenoble | France |
| CHU Lille - Service of Thoracic Surgery | Lille | France |
| Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery | Limoges | France |
| CHU Marseille - Department of Thoracic Surgery | Marseille | France |
| CHU Nice - Pasteur Hospital - Department of Thoracic Surgery | Nice | France |
| Chu Saint-Etienne | Saint-Etienne | 42100 | France |
| CHU Strasbourg - Service of Thoracic Surgery | Strasbourg | France |
| Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse | Toulouse | France |