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)
Cholelithiasis (gallstones) is a common disease of digestive tract in adults. It has been reported that 5-10% or 2 million of Taiwanese adults have gallstones according to National Health Insurance Administration. Laparoscopic cholecystectomy is deemed a surgical standard of care for its safety, effectiveness, and benefits: less post-operative pain, faster recovery, shorter hospital stay, and better cosmesis. However, the advantages of da Vinci surgical system include enhanced vision, wristed instruments, and dexterity of control. Robotic cholecystectomy by single-port SP system is associated with shorter operation time, shorter dissection time, and less post-operative pain. Further improvement in robotic cholecystectomy with CBDE regarding cosmesis and patient satisfaction could be made by adopting da Vinci SP system which preserves enhanced vision and instrument dexterity with only one access port. So far there is no published data on robotic cholecystectomy with CBDE using da Vinci SP. Current study is set forth to evaluate technical feasibility and clinical outcome of robotic biliary surgery using da Vinci SP Surgical System for patients with complex cholelithiasis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
da Vinci SP Surgery System
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGIncidence of conversion rate
The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy.
Time frame: During Surgery
Incidence of Treatment Emergent Adverse Events
The safety endpoint will be assessed as the incidence of all intra-operatvie and post-operative adverse events that occur through the follow up period.
Time frame: up to 6 months
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