Ligasure II: Standard Stapling Versus Ligasure

Centre Hospitalier Universitaire de Saint Etienne

Status and phase

Terminated

Phase 3

Conditions

Lung Resection

Treatments

Device: LigaSure Force Triad Vessel Sealing System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01349426

2010-A00666-33 (Other Identifier)

1008067

Details and patient eligibility

About

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.

Enrollment

172 patients

Sex

All

Ages

18+ years old

Volunteers

No 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