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| Initial experience of laparoendoscopic single-site radical prostatectomy with a novel purpose-built robotic system |
Zheng Wanga,Chao Zhanga,Chengwu Xiaoa,Yang Wanga,Yu Fanga,Baohua Zhua,Shouyan Tanga,Xiaofeng Wua,Hong Xua,Yi Zhoub,Lingfen Wuc,Zhenjie Wua,Bo Yanga,Yi Hec,*( ),Yi Liub,*(),Linhui Wanga,*()
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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 |
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Abstract 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.
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Received: 23 March 2023
Available online: 20 October 2023
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Corresponding Authors:
*E-mail address: heyi@zjxu.edu.cn (Y. He), ziboliuyi@yeah.net (Y. Liu), wanglinhui@smmu.edu.cn (L. Wang).
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Components of the SHURUI system (Beijing Surgerii Technology Co., Ltd., Beijing, China). The SHURUI system comprises a surgeon console, a vision cart, and a patient-side cart (from left to right).
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Instruments and accessories on patient-side carts of SHURUI system. (A) A schematic diagram depicting intracorporeal operation by the deformable robotic arms; (B) The customized Y-configuration sheath and port for single-port surgery.
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Deformable surgical instruments and incisions. (A) Establishing space by scissors and forceps; (B) Suturing the urethra and the bladder neck with needle drivers; (C) The incision of transperitoneal approach; (D) The incision of extraperitoneal approach.
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| Parameter | SR-RARP (n=16) | | Age, year | 69.5±7.1 | | BMI, kg/m2 | 25.1±2.2 | | Medical history | | Hypertension | 8 (50.0) | | Diabetes mellitus | 2 (12.5) | | Coronary artery disease | 1 (6.2) | | Stroke | 1 (6.2) | | ASA physical status classification | | II | 14 (87.5) | | III | 2 (12.5) | | Biopsy GS | | 3+3 | 8 (50.0) | | 3+4 | 5 (31.2) | | 4+3 | 3 (18.8) | | Preoperative PSA, ng/mL | 9.60±3.96 | | Preoperative creatine, μmol/L | 85.1±19.7 |
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Demographics and baseline data.
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| Parameter | SR-RARP (n=16) | | Operative time, min | 226.3±52.0 | | Console time, min | 183.4±48.3 | | Estimated blood loss, mL | 116.3±90.0 | | Surgical approach | | Transperitoneal | 6 (37.5) | | Extraperitoneal | 10 (62.5) | | Cases with additional trocar | 16 (100.0) | | Length of postoperative hospital stay, day | 4.50±0.97 | | Postoperative complication | | Clavien-Dindo Grade II | 2 (12.5) | | VASa | | On surgery day | | 0 | 3 (18.8) | | 1 | 12 (75.0) | | 2 | 1 (6.2) | | Postoperative 24 h | | 0 | 2 (12.5) | | 1 | 14 (87.5) | | Before discharge | | 0 | 9 (56.2) | | 1 | 7 (43.8) | | VSSb | | 0 or 0.5 | 2 (12.5) | | 1 or 1.5 | 10 (62.5) | | 2 or 2.5 | 3 (18.8) | | 3 or 3.5 | 1 (6.2) | | Satisfaction scores of surgeon | 92.4±8.7 | | System performance | 56.2±4.1 | | Comfort level | 32.4±4.0 |
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Perioperative data.
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| Pathology | SR-RARP (n=16) | | pT, n (%) | | 2a | 5 (31.2) | | 2c | 7 (43.8) | | 3a | 3 (18.8) | | 3b | 1 (6.2) | | Postoperative Gleason score, n (%) | | 3+3 | 8 (50.0) | | 3+4 | 6 (37.5) | | 4+3 | 2 (12.5) | | Positive surgical margin, n/total (%) | 4/16 (25.0) | | For pT2a-c patients | 2/12 (16.7) | | For pT3a-b patients | 2/4 (50.0) |
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Pathological data.
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| Oncological and functional follow-up | SR-RARP (n=16) | | Postoperative PSA, ng/mL | | 30 days after discharge | 0.0332±0.0437 | | 6 months after discharge | 0.0219±0.0641 | | Postoperative creatine, μmol/L | | 1 day postoperatively | 76.8±12.6 | | 1 day before discharge | 79.8±13.7 | | 1 month after discharge | 88.0±18.7 | | Postoperative incontinence | | 30 days after discharge | | No urinary pads required | 9 | | 1 urinary pad required within 24 h | 3 | | 2 urinary pads required within 24 h | 4 | | 6 months after discharge | | No urinary pads required | 16 |
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Follow-up data.
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