跳至主要内容
临床试验/NCT05732857
NCT05732857招募中不适用

Perioperative Effects of Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy: a Randomized Prospective Study

Regina Elena Cancer Institute2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
2
主要终点
carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight

研究概览

简要总结

The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.

详细描述

In the literature there are studies on the benefit of valveless trocars in robotic surgery. There are no studies on the potential effects even in complex kidney surgery. Through this randomized study we want to investigate whether the ability to clear CO2 is better using valveless trocars

研究设计

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

  • asa status 1-3
  • surgical classification RENAL or PADUA score >9

排除标准

  • 未提供

结局指标

主要结局

carbon dioxide elimination rate: using the formula where end tidal carbon dioxide multiplied by minute volume divided by arterial pressurea (760mmHg) multiplied by patient weight

时间窗: before extubation

次要结局

  • postoperative acute pain: using the NRS scale(at 1 hour and at 4 hour after the end of surgery)
  • subcutaneous emphysema: through clinical observation at the end of the intervention(at 30 minutes afetr the end of anesthesia)

研究者

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

Ester Forastiere, MD

E Forastiere, MD, Head of Anestesiology and Intensive care Unit

Regina Elena Cancer Institute

研究点 (2)

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