Ligasure II: Standard Stapling Versus Ligasure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Lung Resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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LigaSure

* Arm 1
* Patients undergoing lung surgery

Group Type EXPERIMENTAL

LigaSure Force Triad Vessel Sealing System

Intervention Type DEVICE

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

Automatic Staplers

* Arm 2
* Patients undergoing lung surgery

Group Type ACTIVE_COMPARATOR

LigaSure Force Triad Vessel Sealing System

Intervention Type DEVICE

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

Interventions

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LigaSure Force Triad Vessel Sealing System

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

Intervention Type DEVICE

Other Intervention Names

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Automatic Staplers TA30P, TA55 Endo GIA II MULTIFIRE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No