Grochola Lukasz Filip, Soll Christopher, Zehnder Adrian, Wyss Roland, Herzog Pascal, Breitenstein Stefan
Department of Surgery, Cantonal Hospital of Winterthur, Brauerstrasse 15, 8401, Winterthur, Switzerland.
BMC Surg. 2017 Feb 9;17(1):13. doi: 10.1186/s12893-017-0206-1.
Recent 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.
This 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 1 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.
The 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.
This trial is registered at clinicaltrials.gov (trial number: NCT02485392 ). Registered February 19, 2015.
机器人技术的最新进展表明，与传统单孔腹腔镜胆囊切除术相比，使用达芬奇单孔™平台进行胆囊切除术是安全、可行的，并且学习曲线更短。此外，在实验设置中，与标准单孔腹腔镜检查相比，机器人辅助技术已被证明可减轻外科医生的压力负荷，这表明达芬奇平台具有重要优势。然而，上述观察结果仅基于病例系列、病例报告和实验数据，因为迄今为止尚未进行高质量的临床试验来证明达芬奇单孔™胆囊切除术的益处。
本研究探讨了机器人辅助单孔™胆囊切除术在外科医生压力负荷方面是否比单孔腹腔镜胆囊切除术具有显著优势，同时在围手术期和术后结果方面符合传统单孔手术的标准。该研究设计为单中心、单盲随机对照试验，比较两种手术方法，主要终点是手术时外科医生的身心压力负荷。此外，该研究旨在评估次要终点，如手术时间、转换率、额外套管针置入、术中失血、住院时间、手术费用、健康相关生活质量、美容效果和并发症。患者和病房工作人员在术后1年内均处于盲态。根据先前发表的实验设置结果进行样本量计算，估计外科医生舒适度的效应大小为0.8（检验效能为0.8，α错误水平为0.05，误差幅度为10 - 15%），得出每组30例随机患者。
该研究是第一项将达芬奇单孔™平台与传统腹腔镜手术方法在胆囊切除术中进行比较的随机对照试验，胆囊切除术是普通外科最常进行的手术之一。
该试验已在clinicaltrials.gov注册（试验编号：NCT02485392）。于2015年2月19日注册。
