Ligasure II: Standard Stapling Versus Ligasure

Phase 3

Terminated

• Conditions: Lung Resection
• Interventions: Device: LigaSure Force Triad Vessel Sealing System

• Registration Number: NCT01349426
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-05
• Study First Posted: 2011-05-06
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LigaSure	LigaSure Force Triad Vessel Sealing System	* Arm 1 * Patients undergoing lung surgery
Automatic Staplers	LigaSure Force Triad Vessel Sealing System	* Arm 2 * Patients undergoing lung surgery

Primary Outcome Measures

Name	Time	Method
Rates of post-operative air leak between the two techniques	Day 1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital; 🇫🇷 Bron, France

CHU Clermont Ferrand - Service of Thoracic Surgery; 🇫🇷 Clermont Ferrand, France

CHU Lille - Service of Thoracic Surgery; 🇫🇷 Lille, France

CHU Marseille - Department of Thoracic Surgery; 🇫🇷 Marseille, France

CHU Grenoble - Department of Vascular and Thoracic Surgery; 🇫🇷 Grenoble, France

Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery; 🇫🇷 Limoges, France

CHU Nice - Pasteur Hospital - Department of Thoracic Surgery; 🇫🇷 Nice, France

Chu Saint-Etienne; 🇫🇷 Saint-etienne, France

CHU Strasbourg - Service of Thoracic Surgery; 🇫🇷 Strasbourg, France

Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse; 🇫🇷 Toulouse, France