A single-center prospective, cohort study on the safety and efficacy of laparoscopic surgical robot, Revo-i(MSR-5100)

Yonsei University Health System, Severance Hospital0 个研究点目标入组 13 人开始时间: 待定最近更新: 2021年2月23日

适应症

试验速览

暂无简介。

•1) Adults over 19
•2) Voluntary consent to clinical research and be willing to comply with the protocol
•3) Prostatectomy
•? Person who needs to receive prostatectomy in the following cases:
•-The patient is at low risk group or middle risk group, and the tumor is located at the local site without metastasis
•<Criteria for Prostate Risk Group>
•- Low risk group
•Prostate Cancer Stage (T1-T2a) and Gleason Grade =6 and PSA <10ng / ml
•- Middle Risk group in the prostate
•Prostate cancer stage (T2b-T2c) or Gleason grade 7 or10 ng / ml = PSA = 20 ng / ml
•* Reference) NCCN (National Comprehensive Cancer Network), 2015
•? Others who have been diagnosed to require prostate surgery according to the researcher's judgment
•4) Nephrectomy
•? Persons who needs to receive nephrectomy in the following cases:
•- Localized renal cell carcinoma without metastasis to organs other than the kidney
•Stage 1A, IB, II, III
•* Reference) NCCN (National Comprehensive Cancer Network), 2011
•? Others who needs nephrectomy according to the researcher's judgment

•1) Have mental illness or serious systemic disease
•2) Body Mass Index (BMI) = 30, high obesity
•3) General anesthesia is not possible due to uncontrolled bleeding tendency or lowering of cardiopulmonary function
•4) Have a positive pregnancy or be preparing for pregnancy
•5) Wish to undergo conventional laparoscopy or da Vinci robotic surgery
•6) Prostatectomy
•? Surgical removal of prostate tumor is difficult or life expectancy is short
•? If meet the exclusion criteria below
•<Exclusion Criteria for Prostatectomy>
•- The patient is at high risk group
•<Criteria for Prostate Risk Group>
•- Prostate High Risk Group
•Prostate Cancer Stage (T3a and above) or Gleason Grade = 8 or = 10 or PSA> 20ng / ml
•* Reference) NCCN (National Comprehensive Cancer Network), 2015
•-Have a history of surgery on the prostate, urethra, or bladder neck
•-Have a history of open surgery
•7) Nephrectomy
•? Have a history of upper abdominal open surgery or have had kidney surgery
•? Have a history of chronic inflammation in the kidney or retroperitoneal space
•? Tend to bleed
•? Accompanied by diseases such as kidney, vascular anomaly to the extent that surgery is impossible

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