跳至主要内容
临床试验/NCT01121614
NCT01121614已完成不适用

A Pilot Study to Compare Collateral Damage and Vessel Sealing Ability of LOTUS Ultrasonic Shears, Ethicon Harmonic Scalpel™ and LigaSure™ on Human Mesenteric Blood Vessels

University Hospital Plymouth NHS Trust2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Bursting pressure of sealed vessel

研究概览

简要总结

Ultrasonic cutting-coagulation devices (UCCD) are surgical instruments which use ultrasonic energy to cut through and coagulate tissue. An Ethicon version (trademarked "Harmonic Scalpel" and "Ultracision") is used in a variety of surgical procedures. Its surgical performance has been directly compared with that of electrically powered diathermy instruments in animal and clinical trials. LOTUS is a company based in Ashburton, Devon, which has developed a UCCD that works in a slightly different way to the Harmonic Scalpel. There are also bipolar feedback diathermy instruments which use electrical energy to seal blood vessels, such as LigaSure. The aim of this project is to obtain data to design a fully powered trial to answer the research question: do LOTUS and Ethicon UCCDs and LigaSure bipolar device reliably seal and divide blood vessels? The investigators will also be examining the degree of collateral tissue damage caused by each instrument.

Hypotheses

  • LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure are equivalent at sealing and dividing mesenteric blood vessels.
  • LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure cause equal amount of collateral damage when sealing and dividing blood vessels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

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

  • Patient undergoing laparoscopic or open colorectal resection

排除标准

  • Pregnant or lactating women
  • Patients under eighteen years of age
  • History of coagulation abnormality
  • Inability to understand the nature of the study

结局指标

主要结局

Bursting pressure of sealed vessel

时间窗: 1 day

Designated instrument is used to seal and divide a blood vessel which has been dissected from large bowel mesentery. The pressure at which the seal leaks is measured using a pressure transducer, this is known as the "bursting pressure"

次要结局

  • Success/failure to seal vessel(1 day)
  • Depth of collateral damage(After histological fixation is complete; within one week)

研究者

发起方
University Hospital Plymouth NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验