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

Not Applicable
Completed
Conditions
Neoplasms
Registration Number
KCT0004366
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

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 receive a surgery for pancreatic biliary tract due to one or more of the following reasons:
-Benign or borderline ampullary mass
-Resectable ampulla mass (biliary cancer, pancreatic cancer, duodenal cancer, ampullary cancer, etc.)
-Congenital gallbladder cyst
-adenocarcinoma and early stage lesion of ampulla
-no major organ or vascular invasion
-no severe pancreatitis and cholangitis
4) Considering laparoscopic surgery over da Vinci robot surgery due to cost
5) Others who need difficult pancreatic biliary tract surgery 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 open gastric surgery
7) Liver cirrhosis
8) pancreatic biliary anomaly, other pancreatic biliary diseases, or systemic diseases to the extent that surgery is impossible

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Success rate
Secondary Outcome Measures
NameTimeMethod
Operative time;Intraoperative blood loss;Hospital day;Incidence of complication
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