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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004367

Enrollment

Registered

2019-10-22

Start date

2019-10-30

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : 1) Those who visit the outpatient and deem it necessary to treat the target disease will be referred to this clinical. 2) Those who voluntarily sign the consent form and satisfying

s standard procedures. 4) Perform the surgery of the group on the day of surgery. At this time, a person who has 20 or more experiences with robotic surgery is designated as operator. 5) Observe the n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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) 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

Design outcomes

Primary

Measure	Time frame
Success rate	—

Secondary

Measure	Time frame
Operative time;Intraoperative blood loss;Hospital day;Incidence of complication	—

Countries

Korea, Republic of

Contacts

Public ContactKoon Ho Rha

Yonsei University

Outcome results