Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial

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.

Robotic-assisted cholecystectomy is superior to laparoscopic cholecystectomy in the initial training for surgical novices in an ex vivo porcine model: a randomized crossover study

“…3D vision in laparoscopy helps reducing operative time and complication rate, especially for laparoscopic suturing [4]. Both mental and physical workload can be reduced [2,5] and especially for novices these features of RAS have the potential to shorten learning curves compared to CL [1,[6][7][8][9][10]. It has already been shown that RAS can improve the early learning curve for novices while learning an advanced laparoscopic task such as knot tying.…”

Minimally Invasive Single-Site Cholecystectomy in Obese Patients: Laparoscopic vs. Robotic

“…Previous studies have shown that, when comparing RSSC and LSSC, RSSC is safer, easier to learn, less stressful, and technically easier for the operator to perform. 7,9,16,17 Also, other investigations have detailed that the rates of major complications and open conversion are lower in patients with high BMI compared with cases of RSSC and standard laparoscopic cholecystectomy. 18 Therefore, when comparing RSSC and SFLC in high-BMI patients, RSSC seems to be a safer procedure associated with less morbidity.…”

“…7 Therefore, it is believed that robot singleport surgery is easier to perform than laparoscopic single-port surgery. 8,9 Surgical patients with obesity represent a challenge in minimally invasive surgery and, considering the increasing number of obese patients, 10 difficult cases are expected to increase in number. It is thought to be even more difficult to perform laparoscopic single-port cholecystectomy in patients with high body mass index (BMI).…”

Advances in Gallbladder-Preserving Surgery for Gallbladder Diseases

“…The relationship between cholelithiasis and metabolism, family history and genetic inheritance [32]. The joint study of Ruijin Hospital Affiliated to Shanghai Jiaotong University and Karolinska Institute in Sweden shows that cholesterol gallstone disease belongs to the category of metabolic syndrome.…”