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临床试验/NCT03111797
NCT03111797已完成不适用

Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study

Hospital Nord1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy.

Second outcome was to search eventual cardiac output difference during the surgery in 100 patients (50 in each group) using a non invasive monitoring device of cardiac output

All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were included.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Volunteers
  • Mono lobectomy of lung for early stage cancer (T2Nx and earlier)
  • Video or robot assisted procedure

排除标准

  • Advanced stage of cancer (T3Nx and greater)
  • Need of thoracotomy conversion during procedure
  • Morphine intolerance or addiction.

研究组 & 干预措施

video-assisted lobectomy group

patients operated of lung lobectomy for an early stage cancer using a video-assisted surgical procedure

干预措施: Morphine (Drug)

video-assisted lobectomy group

patients operated of lung lobectomy for an early stage cancer using a video-assisted surgical procedure

干预措施: Cardiac output measure (Other)

robot-assisted lobectomy group

patients operated of lung lobectomy for an early stage cancer using a robot-assisted surgical procedure

干预措施: Morphine (Drug)

robot-assisted lobectomy group

patients operated of lung lobectomy for an early stage cancer using a robot-assisted surgical procedure

干预措施: Cardiac output measure (Other)

结局指标

主要结局

Morphine consumption

时间窗: 48 hours after surgery

morphine consumption for each patient using a self patient - controled morphine pump

次要结局

  • cardiac output(during 30 minutes after incision and optic introduction)

研究者

发起方
Hospital Nord
申办方类型
Other
责任方
Principal Investigator
主要研究者

marc LEONE

Study Director, Clinical professor

Hospital Nord

研究点 (1)

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