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

KCT0004366

Enrollment

Registered

2019-10-22

Start date

2019-11-18

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) 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

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

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 ContactChang Moo Kang

Yonsei University Health System, Severance Hospital

Outcome results