跳至主要内容
临床试验/KCT0006532
KCT0006532已完成未知

Evaluation of the suitability of using ArtiSential in various renal surgery: IDEAL stage 1

Asan Medical Center0 个研究点目标入组 15 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
15

研究概览

简要总结

? Operative and Convalescence Parameters ? Except for R-09 patients with liver cirrhosis as an underlying disease, the surgery and recovery-related indexes are similar to the median values of all patients, and are expected to be similar to those of general robotic surgery patients. ? feasibility ? Laparoscopic surgery using Artisan was impossible in R-09 patient with liver cirrhosis as an underlying disease due to a large amount of bleeding. In general, considering that patients with blood clotting disorders are relatively contraindicated for laparoscopic surgery, R-09 patients are considered inappropriate as subjects for clinical trials in this study. ?Artisanial was able to perform more than 90% of the 9 sub-steps except for the Renorrhaphy step. The difficulty of performing the renorrhaphy phase is due to the long ischemia time, and I think that it can be solved by overcoming the learning curve. ? In the objective indicators for each sub-stage, the operation time of the renorrhaphy stage was rather long, which led to a long ischemia time. As mentioned above, I think it will be improved through overcoming the learning curve. ? Objective indicators ? Two intraoperative complications (Satava Grade II vein injury) occurred at the stage of dissection of the renal pedicle. ? Subjective indicators ? In subjective indicators for each sub-step, ease of use was improved compared to the preclinical study, and it is judged that the analysis of clinical requirements through early clinical experience was helpful. ? Other than that, the height of the operating table is the same as when using a straight instrument, and it is necessary to adjust the inclination of the operating table according to the inside or outside of the patient. It is recommended that the distance between the camera port and the working port be located close to 1~2 cm compared to the straight instrument during port placement. It is judged that the angle between the camera port and the working port is positioned at 110 to 120 degrees to increase the ease of use. ? Considering the characteristics of urology and surgery, which operate over a wide range and require surgery in a standing position, it is judged that the hand-controlled electrode will increase the ease of use rather than the foot-controlled type.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
18(Year) 至 79(Year)(—)
性别
All

入选标准

  • Subjects for radical nephrectomy, partial nephrectomy, or nephroureterectomy, aged >=18 and <80 years

排除标准

  • Unwilling to participate in the study
  • Unable to undergo laparoscopic surgery due to previous abdominal surgery
  • Inappropriate to participate in the study according to the investigator

研究者

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