跳至主要内容
临床试验/NCT01349426
NCT01349426终止3 期

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

Centre Hospitalier Universitaire de Saint Etienne11 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
入组人数
172
试验地点
11
主要终点
Rates of post-operative air leak between the two techniques

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Rates of post-operative air leak between the two techniques

时间窗: Day 1

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (11)

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