Clinical Study for Evaluating the Clinical Safety and Effectiveness of the Automated Robotic Robot, Revo-i Surgical Robot System (Model MSR-5100), Used for General Endoscopic Surgery.
Clinical Study for Evaluating the Clinical Safety and Effectiveness of the Automated Robotic Robot, Revo-i Surgical Robot System (Model MSR-5100), Used for General Endoscopic Surgery.
This study is based on the ergonomic features of the most common surgical procedures, which
 require advanced techniques and relatively difficult operations, such as pancreatobiliary
 surgery, prostatectomy, nephrectomy, colon and rectal resection. This study id designed to
 verify the clinical safety and effectiveness of 'Revo-i Surgical Robot System (Model
 MSR-5100), developed by Mirae Company to overcome the limitations of general laparoscopic
 surgery.
Inclusion Criteria:

 All of the following selection criteria must be met to be enrolled in this clinical trial.

 -  Common Standard

 1. Adults over 19

 2. Voluntary consent to clinical research and willingness to comply with the
 protocol

 -  Pancreaticobiliary tract area surgery

 1. A person deemed to need surgery for pancreaticobiliary tract due to one or more
 of the following reasons:

 -  Benign and borderline periampullary cancer

 -  Resectable masses (biliary cancer, pancreatic cancer, duodenal cancer, AoV
 cancer, etc.) Congenital gallbladder cysts

 -  Endoscopic treatment of adenocarcinoma and early stage lesions of ampulla

 -  There is no major organ or vascular invasion

 -  Lack of severe pancreatitis and cholangitis

 2. Patients considering laparoscopic surgery who cannot perform da Vinci robot
 surgery due to personal expense

 3. Others who have been diagnosed with high latitude pancreaticobiliary tract
 surgery according to the researcher's judgment

 -  Prostatectomy

 1. Persons deemed necessary for prostatectomy in the following cases:

 -The prostate is at low risk or medium risk, and the tumor is located at the
 local site without metastasis Criteria for Prostate Risk Group Prostate low risk
 group Prostate Cancer Stage (T1-T2a) and Gleason Grade ≤6 and PSA <10ng / ml 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

 2. Others who have been diagnosed as requiring prostate surgery according to the
 researcher's judgment

 -  Nephrectomy

 1. Persons deemed necessary for renal resection should:

 Localized renal cell carcinoma without metastasis to organs other than the kidney
 Stage 1A, IB, II, III

 * Reference) NCCN (National Comprehensive Cancer Network), 2011

 2. Others who have been diagnosed with nephrectomy according to the researcher's
 judgment

 -  Colon and Rectal Surgery

 1. A person who needs to have a resection for colon and rectal cancer

 -  Histopathologically confirmed by adenocarcinoma of the rectum or colon

 -  No remote transition (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

 2. Others who have been diagnosed as having to need colon and rectal resection
 according to the researcher's judgment

 Exclusion Criteria:

 -  Common Standard

 1. If you 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. If you have a positive or reactive pregnancy

 5. Patients who wish to undergo conventional laparoscopy or da Vinci robotic surgery

 -  Pancreaticobiliary tract area surgery

 -If you have a history of open abdominal surgery Liver cirrhosis Patients with
 abnormally inoperable pancreatobiliary malformations, other pancreatic biliary
 diseases, or systemic diseases

 -  Prostatectomy

 1. Surgical removal of prostate tumor is difficult or life expectancy is short

 2. Meets the exclusion criteria of prostatectomy below <Exclusion Criteria for
 Prostatectomy>

 -  Clinical study subjects at high risk group Criteria of Prostate Risk Group
 Prostate High Risk Group Prostate Cancer Stage (T3a and above) or Gleason
 class ≥ 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

 -  If you have a history of open surgery

 -  Nephrectomy

 1. If you have a history of epigastric open surgery or have had kidney surgery

 2. History of chronic inflammation in the kidneys and the posterior cavity

 2) prone to bleeding 3) When a disease such as kidney or vascular malformation is
 impossible to the extent that surgery is impossible

 -  Colon and Rectal Surgery

 1. If you have a history of lower abdominal and pelvic laparotomy

 2. prone to bleeding

 3. If you are older than 80 years old

 4. In case of remote transition (M1)

 5. When long-term complications other than adjacent organ invasion (T4b) or primary
 tumor are needed

 6. Accompanied by intestinal obstruction, perforation, or emergency surgery