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 sites10 target enrollmentTBD

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Yonsei University Health System, Severance Hospital
Enrollment: 10
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

who.int

Start Date

TBD

End Date

December 28, 2020

Last Updated

3 years ago

Study Type

Interventional Study

Sex

All

Investigators

Sponsor

Yonsei University Health System, Severance Hospital

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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