Evaluation of Clinical Research on Novel Multiport Robotic Platforms for Urological Surgery According to the IDEAL Framework: A Systematic Review of the Literature.

Background and objective: Several novel multiport robotic systems have been developed and introduced in clinical practice after regulatory approval. The objective of this systematic review was to assess the evolution status of novel robotic platforms approved for clinical use in urological surgery according to the IDEAL framework. Methods: A systematic review was conducted using the Medline and Scopus databases according to the updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (CRD42024503227). Comparative or noncomparative studies reporting on any urological procedures performed with novel robotic platforms (Hugo RAS; Versius, KangDuo, Senhance, REVO-I, Avatera, Hinotori, Dexter, or Toumai) were selected and included in the analysis. Key findings and limitations: Seventy-four eligible studies were included, of which 67 (90.5%) were noncomparative surgical series representing developmental or explorative studies according to the IDEAL criteria. Only one randomised controlled trial (comparing KangDuo vs da Vinci robot-assisted partial nephrectomy) was included. The trial showed comparable perioperative outcomes between the two robotic systems. Four studies assessed clinical outcomes for patients undergoing urological procedures using a REVO-I (1 study), Senhance (2 studies), or Hinotori (1 study) system in comparison to the same procedures performed using a da Vinci system. All studies revealed outcomes comparable to those with the da Vinci system. Limitations include the small sample size in all studies, and assessment of first-generation novel platforms versus the fourth-generation multiarm da Vinci system in most of the comparative studies. Conclusions and clinical implications: A few poor-quality studies have compared the use of novel robotic platforms to da Vinci systems in urological surgery and demonstrated comparable results. Most studies can be classified as developmental or explorative, representing the initial steps of clinical research. Large multicentre series are needed to understand whether these novel robots could offer advantages beyond cost reductions over the da Vinci systems. Patient summary: We reviewed research on new robotic systems for surgery in urology. Several studies have shown the feasibility and safety of these new robots during the most common procedures. Very few studies have assessed clinical outcomes with the new robots in comparison to the reference standard, which is a fourth-generation da Vinci robot. Large multicentre studies are needed to understand whether the new robots could offer advantages other than cost savings over the da Vinci robot.

New multiport robotic surgical systems: a comprehensive literature review of clinical outcomes in urology.

Over the past 20 years, the field of robotic surgery has largely been dominated by the da Vinci robotic platform. Nevertheless, numerous novel multiport robotic surgical systems have been developed over the past decade, and some have recently been introduced into clinical practice. This nonsystematic review aims to describe novel surgical robotic systems, their individual designs, and their reported uses and clinical outcomes within the field of urologic surgery. Specifically, we performed a comprehensive review of the literature regarding the use of the Senhance robotic system, the CMR-Versius robotic system, and the Hugo RAS in urologic procedures. Systems with fewer published uses are also described, including the Avatera, Hintori, and Dexter. Notable features of each system are compared, with a particular emphasis on factors differentiating each system from the da Vinci robotic system.

Potential Contenders for the Leadership in Robotic Surgery.

Purpose: To summarize the scientific published literature on new robotic surgical platforms with potential use in the urological field, reviewing their evolution from presentation until the present day. Our goal is to describe the current characteristics and possible prospects for these platforms. Materials and Methods: A nonsystematic search of the PubMed, Cochrane library's Central, EMBASE, MEDLINE, and Scopus databases was conducted to identify scientific literature about new robotic platforms other than the Da Vinci® system, reviewing their evolution from inception until December 2020. Only English language publications were included. The following keywords were used: "new robotic platforms," "Revo-I robot," "Versius robot," and "Senhance robot." All relevant English-language original studies were analyzed by one author (R.F.) and summarized after discussion with an independent third party (E.M., S.Y., S.P., and M.A.). Results: Since 1995, Intuitive Surgical, Inc., with the Da Vinci surgical system, is the leading company in the robotic surgical market. However, Revo-I®, Versius®, and Senhance® are the other three platforms that recently appeared on the market with available articles published in peer-reviewed journals. Among these three new surgical systems, the Senhance robot has the most substantial scientific proof of its capacity to perform minimally invasive urological surgery and as such, it might become a contender of the Da Vinci robot. Conclusions: The Da Vinci surgical platform has allowed the diffusion of robotic surgery worldwide and showed the different advantages of this type of technique. However, its use has some drawbacks, especially its price. New robotic platforms characterized by unique features are under development. Of note, they might be less expensive compared with the Da Vinci robotic system. We found that these new platforms are still at the beginning of their technical and scientific validation. However, the Senhance robot is in a more advanced stage, with clinical studies supporting its full implementation.

Cholecystectomy using the Revo-i robotic surgical system from Korea: the first clinical study.

This study evaluated the safety and efficacy of the newly developed Revo-i (Meerecompany, Yongin, Republic of Korea) robotic surgical system during robot-assisted cholecystectomy. This prospective, phase I clinical study involved 15 patients with gallbladder-related disease. The primary outcome evaluated was the intraoperative safety of the Revo-i; the secondary outcomes measured were the 30-day postoperative complications and patient satisfaction with the Revo-i's performance. Between August 17 and December 23, 2016, we performed 15 robot-assisted cholecystectomies. The operations were successfully completed, without any conversions to open or laparoscopic approaches. The mean patient age (53.07 years), mean operative time (115.3 ± 17.31 min [± standard deviation]), docking time (10.6 ± 3.16 min), console time (49.7 ± 15.41 min), actual dissection time (33.1 ± 10.53 min), and estimated blood loss (3.33 ± 6.17 mL) were determined. There were no intra- or postoperative complications, including gallbladder perforations. The mean hospital stay was 2.0 ± 1.00 days. Most patients reported satisfaction with the Revo-i's performance. Performing robot-assisted cholecystectomies using the Revo-i is feasible and safe. This report describes the first clinical study of the Revo-i robotic surgical system in human patients.

Retzius-sparing robot-assisted radical prostatectomy using the Revo-i robotic surgical system: surgical technique and results of the first human trial.

OBJECTIVE: To evaluate the safety and proficiency of the Revo-i® robotic platform (Meere Company Inc.) in the treatment of prostate cancer (PCa). PATIENTS AND METHODS: A prospective study was carried out on 17 patients with clinically localized PCa treated between 17 August 2016 and 23 February 2017 at our urology department using the Revo-i. Patients underwent Retzius-sparing robot-assisted radical prostatectomy (RS-RARP). The primary objective was to describe the RS-RARP step-by-step surgical technique using the Revo-i. In addition, the safety of the Revo-i was assessed according to intra-operative and the postoperative complications within 30 days of surgery. Early oncological outcomes were also assessed according to surgical margin status and biochemical recurrence (BCR). Continence was defined as use of no or only one pad. Surgeons' satisfaction with the Revo-i was assessed using the Likert scale. RESULTS: All surgeries were completed successfully, with no conversion to open or laparoscopic surgery. The median patient age was 72 years. The median docking time, console time, urethrovesical anastomosis time and estimated blood loss were 8 min, 92 min, 26 min and 200 mL, respectively. One patient was transfused intra-operatively as a result of blood loss of 1 500 mL. Postoperatively, two patients received blood transfusion, and there were no other serious/major complications. The median hospital stay was 4 days. At 3 months, four patients had positive surgical margins, one patient had BCR, and 15 patients were continent. Most of surgeons were satisfied with the Revo-i performance. CONCLUSIONS: The first human study for the treatment of patients with localized PCa using the Revo-i robotic surgical system was carried out successfully. The peri-operative, early oncological and continence outcomes are encouraging. Further prospective studies are warranted to support our preliminary results.

Robotic surgery: new robots and finally some real competition!

PURPOSE: For the last 20 years, the predominant robot used in laparoscopic surgery has been Da Vinci by Intuitive Surgical. This monopoly situation has led to rising costs and relatively slow innovation. This article aims to discuss the two new robotic devices for laparoscopic surgery which have received regulatory approval for human use in different parts of the world. MATERIALS: A short description of the Senhance Surgical Robotic System and the REVO-I Robot Platform and their pros and cons compared to the Da Vinci system is presented. A discussion about the differences between the three robotic systems now in the market is presented, as well as a short review of the present state of robotic assistance in surgery and where we are headed.

Robot-assisted Fallopian tube transection and anastomosis using the new REVO-I robotic surgical system: feasibility in a chronic porcine model.

OBJECTIVES: To evaluate the feasibility and safety of the new REVO-I robotic platform by performing Fallopian tube transection and anastomosis in live porcine models. SUBJECTS AND METHODS: A prospective chronic animal study was carried out in four crossbred female pigs. The primary outcome was assessment of the pigs' 2-week survival. The secondary outcomes were measurements of intra-operative variables and the complications or difficulties arising when using the REVO-I. RESULTS: Fallopian tube anastomosis was successfully performed in four porcine models. The mean (range) operating time was 66 (46-104 min), docking time 22.25 (14-53) min and console time 18 (13-20) min. The REVO-I robotic system functioned appropriately, with no technical problems or difficulties noted during the procedures. Both the surgeon and the bedside assistants reported ease of use and better performance with subsequent procedures. All pigs were alive 2 weeks after surgery, with no peri-operative complications related to the use of the robot. CONCLUSIONS: This preclinical chronic porcine study showed that the REVO-I robotic surgical system is a feasible and safe robotic instrument that can be used by surgeons to perform skillful robotic procedures in porcine models. Our next objective will be to demonstrate its safety in humans.