aDepartment of Urology, Changhai Hospital, Naval Medical University, Shanghai, China bDepartment of Anesthesiology, Changhai Hospital, Naval Medical University, Shanghai, China cDepartment of Urology, The Affiliated Hospital of Jiaxing University, Zhejiang, China
Objective: This prospective single-arm clinical trial aimed to evaluated the feasibility and safety of the application of the SHURUI system (Beijing Surgerii Technology Co., Ltd., Beijing, China), a novel purpose-built robotic system, in single-port robotic radical prostatectomy.
Methods: Sixteen patients diagnosed with prostate cancer were prospectively enrolled in and underwent robotic radical prostatectomy from October 2021 to August 2022 by the SHURUI single-port robotic surgical system. The demographic and baseline data, surgical, oncological, and functional outcomes as well as follow-up data were recorded.
Results: The mean operative time was 226.3 (standard deviation [SD] 52.0) min, and the mean console time was 183.4 (SD 48.3) min, with the mean estimated blood loss of 116.3 (SD 90.0) mL. The mean length of postoperative hospital stay was 4.50 (SD 0.97) days. Two patients had postoperative complications (Clavien-Dindo Grade II), and both patients improved after conservative treatment. All patients’ postoperative prostate-specific antigen levels decreased to below 0.2 ng/mL 1 month after discharge. The mean prostate-specific antigen level further decreased to a mean of 0.0219 (SD 0.0641) ng/mL 6 months after surgery. Thirty days postoperatively, 12 out of 16 patients reported using no more than one urinary pad per day, and all patients reported satisfactory urinary control without the need for pads 6 months after surgery.
Conclusion: The SHURUI system is safe and feasible in performing radical prostatectomy via both transperitoneal and extraperitoneal approaches. Tumor control and urinary continence were satisfying for patients enrolled in. The next phase involves conducting a large-scale, multicenter randomized controlled trial to thoroughly assess the effectiveness and safety of the new technology in a broader population.
. [J]. Asian Journal of Urology, 2023, 10(4): 467-474.
Zheng Wang, Chao Zhang, Chengwu Xiao, Yang Wang, Yu Fang, Baohua Zhu, Shouyan Tang, Xiaofeng Wu, Hong Xu, Yi Zhou, Lingfen Wu, Zhenjie Wu, Bo Yang, Yi He, Yi Liu, Linhui Wang. Initial experience of laparoendoscopic single-site radical prostatectomy with a novel purpose-built robotic system. Asian Journal of Urology, 2023, 10(4): 467-474.
Kaouk JH, Autorino R, Kim FJ, Han DH, Lee SW, Sun Y, et al. Laparoendoscopic single-site surgery in urology: worldwide multi-institutional analysis of 1076 cases. Eur Urol 2011; 60: 998-1005.
doi: 10.1016/j.eururo.2011.06.002
pmid: 21684069
[2]
Rao PP, Rao PP, Bhagwat S. Single-incision laparoscopic surgerydcurrent status and controversies. J Minimal Access Surg 2011; 7:6-16.
doi: 10.4103/0972-9941.72360
[3]
Bertolo R, Garisto J, Gettman M, Kaouk J. Novel system for robotic single-port surgery: feasibility and state of the art in urology. Eur Urol Focus 2018; 4:669-73.
doi: S2405-4569(18)30152-4
pmid: 29914841
[4]
Mattevi D, Luciani LG, Vattovani V, Chiodini S, Puglisi M, Malossini G. First case of robotic laparoendoscopic single-site radical prostatectomy with single-site VesPa platform. J Robot Surg 2018; 12:381-5.
doi: 10.1007/s11701-017-0724-y
pmid: 28688033
[5]
Chen Y, Zhang C, Wu Z, Zhao J, Yang B, Huang J, et al. The SHURUI system: a modular continuum surgical robotic platform for multiport, hybrid-port, and single-port procedures. IEEE ASME Trans Mechatron 2021; 27:3186-97.
doi: 10.1109/TMECH.2021.3110883
[6]
Dai ZC, Wu ZH, Zhao JR, Xu K. A robotic laparoscopic tool with enhanced capabilities and modular actuation. Sci China-Technol Sci 2019; 62:47-59.
doi: 10.1007/s11431-018-9348-9
[7]
Bilbro NA, Hirst A, Paez A, Vasey B, Pufulete M, Sedrakyan A, et al. The IDEAL reporting guidelines: a Delphi consensus statement stage specific recommendations for reporting the evaluation of surgical innovation. Ann Surg 2021; 273:82-5.
doi: 10.1097/SLA.0000000000004180
[8]
Doyle DJ, Hendrix JM, Garmon EH. American Society of Anesthesiologists classification. Treasure Island (FL): StatPearls Publishing [Last Update: December 4, 2022]. https://www.ncbi.nlm.nih.gov/books/NBK441940/. [Accessed March 23, 2023].
Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil 1990; 11:256-60.
doi: 10.1097/00004630-199005000-00014
pmid: 2373734
[11]
Binder J, Jones J, Bentas W, Wolfram M, Brautigam R, Probst M, et al. [Robot-assisted laparoscopy in urology. Radical prostatectomy and reconstructive retroperitoneal interventions]. Urologe 2002; 41:144-9. [Article in German].
doi: 10.1007/s00120-002-0178-2
[12]
Menon M, Shrivastava A, Tewari A, Sarle R, Hemal A, Peabody JO, et al. Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol 2002; 168:945-9.
doi: 10.1097/01.ju.0000023660.10494.7d
pmid: 12187196
[13]
Novara G, Ficarra V, Mocellin S, Ahlering TE, Carroll PR, Graefen M, et al. Systematic review and meta-analysis of studies reporting oncologic outcome after robot-assisted radical prostatectomy. Eur Urol 2012; 62:382-404.
doi: 10.1016/j.eururo.2012.05.047
pmid: 22749851
[14]
Ficarra V, Cavalleri S, Novara G, Aragona M, Artibani W. Evidence from robot-assisted laparoscopic radical prostatectomy: a systematic review. Eur Urol 2007; 51:45-56.
doi: 10.1016/j.eururo.2006.06.017
pmid: 16854519
[15]
Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, et al. Systematic review and meta-analysis of studies reporting urinary continence recovery after robotassisted radical prostatectomy. Eur Urol 2012; 62:405-17.
doi: 10.1016/j.eururo.2012.05.045
[16]
Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, et al. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol 2009; 55:1037-63.
doi: 10.1016/j.eururo.2009.01.036
pmid: 19185977
[17]
Yaxley JW, Coughlin GD, Chambers SK, Occhipinti S, Samaratunga H, Zajdlewicz L, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet 2016; 388:1057-66.
doi: S0140-6736(16)30592-X
pmid: 27474375
[18]
Haber GP, White MA, Autorino R, Escobar PF, Kroh MD, Chalikonda S, et al. Novel robotic da Vinci instruments for laparoendoscopic single-site surgery. Urology 2010; 76: 1279-82.
doi: 10.1016/j.urology.2010.06.070
[19]
Vigneswaran HT, Schwarzman LS, Francavilla S, Abern MR, Crivellaro S. A comparison of perioperative outcomes between single-port and multiport robot-assisted laparoscopic prostatectomy. Eur Urol 2020; 77:671-4.
doi: S0302-2838(20)30206-2
pmid: 32279904
[20]
Lenfant L, Sawczyn G, Aminsharifi A, Kim S, Wilson CA, Beksac AT, et al. Pure single-site robot-assisted radical prostatectomy using single-port versus multiport robotic radical prostatectomy: a single-institution comparative study. Eur Urol Focus 2021; 7:964-72.
doi: 10.1016/j.euf.2020.10.006
pmid: 33160915
[21]
Ju GQ, Wang ZJ, Shi JZ, Zhang ZQ, Wu ZJ, Yin L, et al. A comparison of perioperative outcomes between extraperitoneal robotic single-port and multiport radical prostatectomy with the da Vinci Si surgical system. Asian J Androl 2021; 23:640-7.
doi: 10.4103/aja.aja_50_21
[22]
Wu Z, Wang J, Wang J, Bao Y, Xu H, Liu B, et al. [Robotic laparoendoscopic single-site (LESS) adrenalectomy: report of preliminary clinical application]. J Clin Urol 2017; 32:437-9 [Article in Chinese].
[23]
Sun YH, Wang LH, Yang B, Xu CL, Hou JG, Xiao L, et al. [Singleport transumbilical laparoscopical nephrectomy: initial clinical experience of three cases]. Chin J Surg 2009; 47:1709-11. [Article in Chinese].
[24]
Wang L, Liu B, Wu Z, Yang Q, Chen W, Sheng H, et al. Comparison of single-surgeon series of transperitoneal laparoendoscopic single-site surgery and standard laparoscopic adrenalectomy. Urology 2012; 79:577-83.
doi: 10.1016/j.urology.2011.09.052
pmid: 22386401
[25]
Wang L, Liu B, Wu Z, Yang Q, Chen W, Xu Z, et al. A matchedpair comparison of laparoendoscopic single-site surgery and standard laparoscopic radical nephrectomy by a single urologist. J Endourol 2012; 26:676-81.
doi: 10.1089/end.2011.0161
[26]
Kaouk J, Aminsharifi A, Wilson CA, Sawczyn G, Garisto J, Francavilla S, et al. Extraperitoneal versus transperitoneal single port robotic radical prostatectomy: a comparative analysis of perioperative outcomes. J Urol 2020; 203: 1135-40.
doi: 10.1097/JU.0000000000000700
pmid: 31846392
[27]
Saidian A, Fang AM, Hakim O, Magi-Galluzzi C, Nix JW, Rais-Bahrami S. Perioperative outcomes of single vs. multi-port robotic assisted radical prostatectomy: a single institutional experience. J Urol 2020; 204:490-5.
doi: 10.1097/JU.0000000000000811
pmid: 32091305
[28]
Covas Moschovas M, Bhat S, Onol F, Rogers T, Patel V. Early outcomes of single-port robot-assisted radical prostatectomy: lessons learned from the learning-curve experience. BJU Int 2021; 127:114-21.
doi: 10.1111/bju.v127.1
[29]
Kaouk JH, Garisto J, Sagalovich D, Dagenais J, Bertolo R, Klein E. Robotic single-port partial prostatectomy for anterior tumors: transvesical approach. Urology 2018; 118:242. https://doi.org/10.1016/j.urology.2018.03.034.
doi: S0090-4295(18)30291-7
pmid: 29704582
[30]
Chang Y, Qu M, Wang L, Yang B, Chen R, Zhu F, et al. Roboticassisted laparoscopic radical prostatectomy from a single Chinese center: a learning curve analysis. Urology 2016; 93: 104-11.
doi: 10.1016/j.urology.2016.03.036
[31]
Agarwal DK, Sharma V, Toussi A, Viers BR, Tollefson MK, Gettman MT, et al. Initial experience with da Vinci single-port robot-assisted radical prostatectomies. Eur Urol 2020; 77: 373-9.
doi: S0302-2838(19)30280-5
pmid: 31010600
[32]
Thompson JE, Egger S, Bohm M, Siriwardana AR, Haynes AM, Matthews J, et al. Superior biochemical recurrence and longterm quality-of-life outcomes are achievable with robotic radical prostatectomy after a long learning curve-updated analysis of a prospective single-surgeon cohort of 2206 consecutive cases. Eur Urol 2018; 73:664-71.
doi: S0302-2838(17)31027-8
pmid: 29273404
