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临床试验/NCT00562900
NCT00562900已完成4 期

Robotic Assisted Versus Laparoscopic Cholecystectomy -

University of Zurich1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年12月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
complications

研究概览

简要总结

Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and surgical experience.

  • Trial with surgical intervention

详细描述

Cholecystectomy is used as a starting procedure for robotic-assisted technology in general surgery by most centers. Surprisingly, data is lacking regarding patient outcome or associated costs compared to the use of conventional laparoscopic surgery.

The study is designed to assess the potential benefits of robotic-assisted cholecystectomy. To achieve a high level of evidence we chose a prospective case matched controlled methodology. Three experienced and one junior (2nd yr) surgeon are involved, and were fully trained with the robot prior to initiating the study including tasks in a training box on pig livers and 5 cholecystectomies performed on humans with this technology. Each patient operated with the robotic system is retrospectively matched one by one with patients who underwent a laparoscopic cholecystectomy.

The robotic assisted operations are performed with the 3- arm Da Vinci robot system (Da Vinci Robot, Intuitive Surgical). Similar to the laparoscopic technique an additional fourth trocar was used to retract the gallbladder. The positioning (French) of the patients and the trocars are also comparable to the conventional laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Non 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
否

入选标准

  • •Cholecystectomy due to symptomatic cholecystolithiasis
  • •Acute or chronic cholecystitis

排除标准

  • •Patients < 18 years
  • •Primary open cholecystectomy

研究组 & 干预措施

A, robotic

Active Comparator

干预措施: robotic assisted cholecystectomy (Procedure)

B, laparoscopic

Active Comparator

干预措施: Laparoscopic cholecystectomy (Procedure)

结局指标

主要结局

complications

时间窗: Dec 04 - Feb 06

次要结局

  • Conversion rates, operative time, hospital-costs(Dec 2004 - Feb 2006)

研究者

申办方类型
Other

研究点 (1)

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