Clinical trial NCT01349426: Ligasure II: Standard Stapling Versus Ligasure
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Resection
Keywords: Lung resection
Parenchymal pneumostasis, haemostasis
Fissure closure
Automatic staplers,LigaSure, Force Triad Generator
Bipolar fusion
Procedure cost
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2011-05-06
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rates of post-operative air leak between the two techniques
timeFrame: Day 1
Secondary outcomes:
measure: Compare the number of lung stitches between LigaSure device and standard staplers
timeFrame: Day 1
measure: Evaluate the cost of LigaSure vs standard staplers in similar procedures including the cost of each instrument and the staple loads fired.
timeFrame: Day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand - Service of Thoracic Surgery
city: Grenoble
country: France
facility: CHU Grenoble - Department of Vascular and Thoracic Surgery
city: Lille
country: France
facility: CHU Lille - Service of Thoracic Surgery
city: Limoges
country: France
facility: Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery
city: Marseille
country: France
facility: CHU Marseille - Department of Thoracic Surgery
city: Nice
country: France
facility: CHU Nice - Pasteur Hospital - Department of Thoracic Surgery
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
city: Strasbourg
country: France
facility: CHU Strasbourg - Service of Thoracic Surgery
city: Toulouse
country: France
facility: Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse
Study officials:
affiliation: CHU Sainte-Etienne
name: TIFFET Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References: