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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pancreaticobiliary disease | Experimental | 10 pancreaticobiliary disease cases |
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| Urinary tract disease | Experimental | 13 urinary tract disease cases |
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| Colon disease | Experimental | 10 colon disease cases |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revo-i robotic surgery system (Model MSR-5100) | Procedure | for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general HBP surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operation success rate | Surgery is complete without significant complications up to 24 hours after surgery and without conversion to other operations (laparotomy or laparoscopy) | 24hours after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Operative outcome | Operation time (minute) | immediate postoperation |
| Operative outcome | Intraoperative bleeding volume (ml) | immediate postoperation |
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Inclusion Criteria:
All of the following selection criteria must be met to be enrolled in this clinical trial.
Common Standard
Pancreaticobiliary tract area surgery
A person deemed to need surgery for pancreaticobiliary tract due to one or more of the following reasons:
Patients considering laparoscopic surgery who cannot perform da Vinci robot surgery due to personal expense
Others who have been diagnosed with high latitude pancreaticobiliary tract surgery according to the researcher's judgment
Prostatectomy
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
Others who have been diagnosed as requiring prostate surgery according to the researcher's judgment
Nephrectomy
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
Others who have been diagnosed with nephrectomy according to the researcher's judgment
Colon and Rectal Surgery
A person who needs to have a resection for colon and rectal cancer
Others who have been diagnosed as having to need colon and rectal resection according to the researcher's judgment
Exclusion Criteria:
Common Standard
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
Surgical removal of prostate tumor is difficult or life expectancy is short
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Moo Kang | Contact | 82-2-2228-2135 | CMKANG@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12187196 | Background | Menon M, Shrivastava A, Tewari A, Sarle R, Hemal A, Peabody JO, Vallancien G. Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol. 2002 Sep;168(3):945-9. doi: 10.1016/S0022-5347(05)64548-X. |
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In a study involving relatively small groups of 10 to 50 people, the study showed a high success rate of more than 90% similar to the study of more than 100 large groups, and the stability was well proven.
total 33 patients (10 pancreaticobiliary tracts, 13 urinary tract areas, 10 colonic areas), the minimum number of clinical studies that can be statistically analyzed within the limits to meet the study objective of evaluating the "accuracy of procedure"
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| Revo-i robotic surgery system (Model MSR-5100) | Procedure | for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general Uro surgery |
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| Revo-i robotic surgery system (Model MSR-5100) | Procedure | for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general colorectal surgery |
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| Operative outcome | Length of stay (day) | 1 month after operation |
| Operative outcome | Complication rate (%) | 1 month after operation |