Jihad H Kaouk1, Georges-Pascal Haber2, Riccardo Autorino2, Sebastien Crouzet3, Adil Ouzzane4, Vincent Flamand4, Arnauld Villers4. 1. Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: kaoukj@ccf.org. 2. Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA. 3. Department of Urology and Transplantation, Edouard Herriot Hospital, Lyon, France. 4. Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.
Abstract
BACKGROUND: The idea of performing a laparoscopic procedure through a single abdominal incision was conceived with the aim of expediting postoperative recovery. OBJECTIVE: To determine the clinical feasibility and safety of single-port urologic procedures by using a novel robotic surgical system. DESIGN, SETTING, AND PARTICIPANTS: This was a prospective institutional review board-approved, Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) phase 1 study. After enrollment, patients underwent a major urologic robotic single-port procedure over a 3-wk period in July 2010. The patients were followed for 3 yr postoperatively. INTERVENTION: Different types of urologic surgeries were performed using the da Vinci SP Surgical System. This system is intended to provide the same core clinical capabilities as the existing multiport da Vinci system, except that three articulating endoscopic instruments and an articulating endoscopic camera are inserted into the patient through a single robotic port. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The main outcomes were the technical feasibility of the procedures (as measured by the rate of conversions) and the safety of the procedures (as measured by the incidence of perioperative complications). Secondary end points consisted of evaluating other key surgical perioperative outcomes as well as midterm functional and oncologic outcomes. RESULTS AND LIMITATIONS: A total of 19 patients were enrolled in the study. Eleven of them underwent radical prostatectomy; eight subjects underwent nephrectomy procedures (partial nephrectomy, four; radical nephrectomy, two; and simple nephrectomy, two). There were no conversions to alternative surgical approaches. Overall, two major (Clavien grade 3b) postoperative complications were observed in the radical prostatectomy group and none in the nephrectomy group. At 1-yr follow-up, one radical prostatectomy patient experienced biochemical recurrence, which was successfully treated with salvage radiation therapy. The median warm ischemia time for three of the partial nephrectomies was 38 min. At 3-yr follow-up all patients presented a preserved renal function; none had tumor recurrence. Study limitations include the small sample and the lack of a control group. CONCLUSIONS: We describe the first clinical application of a novel robotic platform specifically designed for single-port urologic surgery. Major urologic procedures were successfully completed without conversions. Further assessment is warranted to corroborate these promising findings. PATIENT SUMMARY: A novel purpose-built robotic system enables surgeons to perform safely and effectively a variety of major urologic procedures through a single small abdominal incision. TRIAL REGISTRATION: The study was registered on www.ClinicalTrials.gov (NCT02136121).
BACKGROUND: The idea of performing a laparoscopic procedure through a single abdominal incision was conceived with the aim of expediting postoperative recovery. OBJECTIVE: To determine the clinical feasibility and safety of single-port urologic procedures by using a novel robotic surgical system. DESIGN, SETTING, AND PARTICIPANTS: This was a prospective institutional review board-approved, Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) phase 1 study. After enrollment, patients underwent a major urologic robotic single-port procedure over a 3-wk period in July 2010. The patients were followed for 3 yr postoperatively. INTERVENTION: Different types of urologic surgeries were performed using the da Vinci SP Surgical System. This system is intended to provide the same core clinical capabilities as the existing multiport da Vinci system, except that three articulating endoscopic instruments and an articulating endoscopic camera are inserted into the patient through a single robotic port. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The main outcomes were the technical feasibility of the procedures (as measured by the rate of conversions) and the safety of the procedures (as measured by the incidence of perioperative complications). Secondary end points consisted of evaluating other key surgical perioperative outcomes as well as midterm functional and oncologic outcomes. RESULTS AND LIMITATIONS: A total of 19 patients were enrolled in the study. Eleven of them underwent radical prostatectomy; eight subjects underwent nephrectomy procedures (partial nephrectomy, four; radical nephrectomy, two; and simple nephrectomy, two). There were no conversions to alternative surgical approaches. Overall, two major (Clavien grade 3b) postoperative complications were observed in the radical prostatectomy group and none in the nephrectomy group. At 1-yr follow-up, one radical prostatectomy patient experienced biochemical recurrence, which was successfully treated with salvage radiation therapy. The median warm ischemia time for three of the partial nephrectomies was 38 min. At 3-yr follow-up all patients presented a preserved renal function; none had tumor recurrence. Study limitations include the small sample and the lack of a control group. CONCLUSIONS: We describe the first clinical application of a novel robotic platform specifically designed for single-port urologic surgery. Major urologic procedures were successfully completed without conversions. Further assessment is warranted to corroborate these promising findings. PATIENT SUMMARY: A novel purpose-built robotic system enables surgeons to perform safely and effectively a variety of major urologic procedures through a single small abdominal incision. TRIAL REGISTRATION: The study was registered on www.ClinicalTrials.gov (NCT02136121).
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