Ligasure II: Standard Stapling Versus Ligasure

NCT01349426 | Terminated Phase 3

• 2 other identifiers: 10080672010-A00666-33
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 10

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.

Conditions

Lung Resection

Keywords

Lung resection; Parenchymal pneumostasis, haemostasis; Fissure closure; Automatic staplers,LigaSure, Force Triad Generator; Bipolar fusion; Procedure cost

Outcome Measures

Primary Outcomes (1)

• Rates of post-operative air leak between the two techniques

  Day 1

Secondary Outcomes (2)

• 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

Study Arms (2)

LigaSure

EXPERIMENTAL

* Arm 1 * Patients undergoing lung surgery

Device: LigaSure Force Triad Vessel Sealing System

Automatic Staplers

ACTIVE COMPARATOR

* Arm 2 * Patients undergoing lung surgery

Device: LigaSure Force Triad Vessel Sealing System

Interventions

LigaSure Force Triad Vessel Sealing System DEVICE

Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers

Also known as: Automatic Staplers TA30P, TA55, Endo GIA II MULTIFIRE

Automatic Staplers; LigaSure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Patients scheduled for thoracotomy, lobectomy or bilobectomy
• Patients must give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Medtronic - MITG: collaborator

Study Sites (10)

CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital

Bron, France

Location

CHU Clermont Ferrand - Service of Thoracic Surgery

Clermont-Ferrand, France

Location

CHU Grenoble - Department of Vascular and Thoracic Surgery

Grenoble, France

Location

CHU Lille - Service of Thoracic Surgery

Lille, France

Location

Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery

Limoges, France

Location

CHU Marseille - Department of Thoracic Surgery

Marseille, France

Location

CHU Nice - Pasteur Hospital - Department of Thoracic Surgery

Nice, France

Location

Chu Saint-Etienne

Saint-Etienne, 42100, France

Location

CHU Strasbourg - Service of Thoracic Surgery

Strasbourg, France

Location

Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse

Toulouse, France

Location

Study Officials

• TIFFET Olivier, MD

  CHU Sainte-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 6, 2011
• Study Start: September 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

FR (10)