Cohort study on the safety and efficacy of laparoscopic surgical robot, Revo-i(MSR-5100)

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0004323
• Lead Sponsor: Yonsei University Health System, Severance Hospital

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-28
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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
11) With intestinal obstruction, perforation, or emergency surgery

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate

Secondary Outcome Measures

Name	Time	Method
Operative time;Intraoperative blood loss;Hospital day;Incidence of complication