RecruitingNot ApplicableNCT06852937
Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis
Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Complex Cholelithiasis and Choledocholithiasis
Sponsor
National Taiwan University Hospital
Enrollment
25 participants
Start Date
Dec 21, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A prospective, interventional, single arm study to investigate clinical feasibility of single-stage cholecystectomy and common bile duct exploration using da Vinci SP Surgical System (robotic surgery)
Eligibility
Min Age: 20 Years
Inclusion Criteria8
- Age 20 years or more
- Symptomatic cholelithiasis with or without choledocholithiasis, symptomatic chronic cholecystitis with or without biliary tract injury or stricture
- Indication of cholecystectomy with or without common bile duct exploration and deemed feasible for robotic surgery
- Patient not feasible or have failed stone extraction or intervention for choledocholithiasis by endoscopic retrograde cholangiopancreatography for patients with 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 eligible for this trial, but the associated agents should be discontinued 5 days prior to the operation day. Patients who are taking Wafarin should be admitted two days earlier for bridging to Heparin. Other medications for underlying diseases can be taken as usual.
- With informed consent
Exclusion Criteria12
- 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 for robotic surgery
- Active infectious disease
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions, such as: severe heart disease (NYHA functional class 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
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Interventions
DEVICEda Vinci SP Surgery System
da Vinci SP Surgery System
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06852937
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