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临床试验/KCT0004323
KCT0004323已完成未知

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 10 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
10

研究概览

简要总结

Robotic surgeries have become readily, and widely available worldwide. There is a limited choice for system provider Revo-i has proved to be just as safe and feasible as other minimally invasive surgery we perform, according to our data. We hope that competition among robotic system market may provide us with improved systems at better prices. Revo-I system is compatible to other MIS systems commonly used at the moment It provides all the advantages of robotic system and at a lower cost, which has been the main drawback of robotic surgeries

研究设计

研究类型
Interventional Study

入排标准

年龄范围
19(Year) 至 80(Year)(—)
性别
All

入选标准

  • 1) Adults over 19
  • 2) Voluntary consent to clinical research and be willing to comply with the protocol
  • 3) A person who needs to have a resection for colon and rectal cancer
  • -Histopathologically confirmed by adenocarcinoma of the rectum or colon
  • -No remote metastasis (M0)
  • -Primary tumor without other peripheral organ involvement (T1-T4a)
  • -When intestinal obstruction is not accompanied
  • -In case of elective surgery
  • -Does not require resection of any organ other than the primary tumor
  • 4) Others who have been diagnosed as having to receive a colon and rectal resection according to the researcher's judgment

排除标准

  • 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) Have a history of lower abdominal and pelvic laparotomy
  • 7) Prone to bleeding
  • 8) Older than 80 years old
  • 9) In case of remote metastasis (M1)
  • 10) Adjacent organ invasion (T4b) or require a resection of any organ other than the primary tumor
  • 11) With intestinal obstruction, perforation, or emergency surgery

研究者

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