Phase
Condition
Liver Disorders
Gall Bladder Disorders
Treatment
da Vinci SP Surgery System
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 20 years or more
Symptomatic cholelithiasis with or without choledocholithiasis, symptomatic chroniccholecystitis with or without biliary tract injury or stricture
Indication of cholecystectomy with or without common bile duct exploration anddeemed feasible for robotic surgery
Patient not feasible or have failed stone extraction or intervention forcholedocholithiasis by endoscopic retrograde cholangiopancreatography for patientswith choledocholithiasis could be included
ASA physical status classification 1-2 and adequate organ function
Patients willing and able to comply with study protocol requirements and follow-up
Patients who are taking anti-platelet or anti-coagulation medications are eligiblefor this trial, but the associated agents should be discontinued 5 days prior to theoperation day. Patients who are taking Wafarin should be admitted two days earlierfor bridging to Heparin. Other medications for underlying diseases can be taken asusual.
With informed consent
Exclusion
Exclusion Criteria:
Severe acute cholecystitis
Suspected biliary tract cancer or untreated biliary tract cancer
BMI ≥35 or BMI <18.5
Unable to tolerate robotic surgery position
Severe adhesion due to prior abdominopelvic surgery
Prior major upper abdominal surgery judged by the investigator as not feasible forrobotic surgery
Active infectious disease
Severe concomitant illness that drastically shortens life expectancy or increasesrisk of therapeutic interventions, such as: severe heart disease (NYHA functionalclass III-IV) or severe lung disease (GOLD Group C-D)
Cannot follow trial-required procedures
Concomitant systemic or pelvic disease that increases the risk of surgery
Patients with coagulopathy
Emergency surgery
Study Design
Study Description
Connect with a study center
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
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