Abstract
BackgroundRecent advances in robotic technology suggest that the utilization of the da Vinci Single-Site™ platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. Moreover, the robot-assisted technology has been shown to reduce the surgeon’s stress load compared to standard single-incision laparoscopy in an experimental setup, suggesting an important advantage of the da Vinci platform. However, the above-mentioned observations are based solely on case series, case reports and experimental data, as high-quality clinical trials to demonstrate the benefits of the da Vinci Single-Site™ cholecystectomy have not been performed to date.MethodsThis study addresses the question whether robot-assisted Single-Site™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon’s stress load, while matching the standards of the conventional single-incision approach with regard to peri- and postoperative outcomes. It is designed as a single centre, single-blinded randomized controlled trial, which compares both surgical approaches with the primary endpoint surgeon’s physical and mental stress load at the time of surgery. In addition, the study aims to assess secondary endpoints such as operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, costs of procedure, health-related quality of life, cosmesis and complications. Patients as well as ward staff are blinded until the 1st postoperative year. Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon’s comfort of 0.8 (power of 0.8, alpha-error level of 0.05, error margin of 10–15%) resulted in a number of 30 randomized patients per arm.DiscussionThe study is the first randomized controlled trial that compares the da Vinci Single Site™ platform to conventional laparoscopic approaches in cholecystectomy, one of the most frequently performed operations in general surgery.Trial registrationThis trial is registered at clinicaltrials.gov (trial number: NCT02485392). Registered February 19, 2015.
Highlights
Recent advances in robotic technology suggest that the utilization of the da Vinci Single-SiteTM platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy
Despite beneficial patient-related results of laparoscopic single port cholecystectomy compared to the multiport laparoscopic operation, surgeons do not feel comfortable with the single port technology [6]
Preliminary evidence from case reports and case–control studies suggests that the utilization of the da Vinci Single-SiteTM technology for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy [1,2,3,4]
Summary
Recent advances in robotic technology suggest that the utilization of the da Vinci Single-SiteTM platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. The Da Vinci Single-SiteTM technology provides several putative advantages over standard laparoscopic single-incision approaches such as the utilization of ergonomic, curved robot-assisted devices that preserve triangulation within the operative field, the reassignment of the crossing instruments to the opposite side, motion scaling and a stable 3D view of the operating field. These interesting features are thought to reduce eye strain, improve the ergonomic outcomes for surgeons and minimize both the mental and the physical workload associated with single-incision laparoscopy. All of the participating surgeons that had previous experience with single-incision laparoscopy cholecystectomy agreed that the robotic approach is easier than the single-incision laparoscopic technique
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