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临床试验/NCT00683293
NCT00683293已完成不适用

Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques

Kantonsspital Aarau1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年11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
100
试验地点
1
主要终点
Duration of Surgery

研究概览

简要总结

The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

详细描述

During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.

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
Female
接受健康志愿者

入选标准

  • Indication for laparoscopic hysterectomy
  • Patients BMI < 40
  • Signed consent

排除标准

  • Estimated uterus weight >400 g
  • No combination with other procedures
  • No underlying malignant condition

结局指标

主要结局

Duration of Surgery

时间窗: after surgey

•Mean Time to complete surgery from cut to suture

次要结局

  • Complications(up to 2 weeks)

研究者

发起方
Kantonsspital Aarau
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitri Sarlos

Head Gynaecology and oncological Gynaecology

Kantonsspital Aarau

研究点 (1)

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