跳至主要内容
临床试验/NCT01008709
NCT01008709终止不适用

Minimally Invasive Urologic Surgery Clip Evaluation: Can We Improve Our Surgical Technique, Reduce Costs and Waste With the Aesculap U-clip Versus the Tele-Flex Hemolock Clip?

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
2
主要终点
significant difference in clip misfire and misapplication rates

研究概览

简要总结

Intracorporeal suturing and knot tying during robotic prostatectomy and laparoscopic and robotic renal surgery have historically been considered the most technically challenging and time consuming aspects of these procedures. With improved operative technique as well as the use of innovative surgical devices, vascular control during these surgeries is often less cumbersome as compared with traditional techniques. Current standard methods of hemostasis include the use of clips, of which the most popular design is the Hemolock, a locking, nonabsorbable plastic clip, or the use of the very expensive endomechanical stapler. Unfortunately while they are associated with time savings in the operating room, there is a great deal of disposable costs associated with these various devices as well as a not insignificant device malfunction rate reported in the literature. The aim of this case-controlled study is to evaluate the Aesculap U-clip device compared to our current technique of vascular control using the Teleflex Hemolock clip device during minimally invasive genitourinary surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Device Feasibility
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

  • All patients ≥ 18 years old with genitourinary malignancy either prostate cancer or kidney renal masses undergoing minimally invasive genitourinary organ removal will be included in this small pilot study.

排除标准

  • 未提供

结局指标

主要结局

significant difference in clip misfire and misapplication rates

时间窗: 1month

次要结局

  • OR time(1 day)
  • surgeon impression of the ease of application(1 day)
  • blood loss / need for transfusion(1 month)
  • Need for repeat procedure(1 month)
  • number of clips used(1 day)
  • predicted cost differential (or at least charge differential)(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stanley Duke Herrell

Associate Professor

Vanderbilt University Medical Center

研究点 (2)

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