title: A novel robotic system for single-port urologic surgery: first clinical investigation.
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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  The study was registered on www.ClinicalTrials.gov (NCT02136121).
authors.affiliation: Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address: kaoukj@ccf.org.
authors.forename: Jihad H
authors.initials: JH
authors.lastname: Kaouk
authors.affiliation: Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Georges-Pascal
authors.initials: GP
authors.lastname: Haber
authors.affiliation: Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Autorino
authors.affiliation: Department of Urology and Transplantation, Edouard Herriot Hospital, Lyon, France.
authors.forename: Sebastien
authors.initials: S
authors.lastname: Crouzet
authors.affiliation: Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.
authors.forename: Adil
authors.initials: A
authors.lastname: Ouzzane
authors.affiliation: Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Flamand
authors.affiliation: Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.
authors.forename: Arnauld
authors.initials: A
authors.lastname: Villers
mesh_terms: D000368:Aged; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000601:surgery*; D010535:Laparoscopy / Q000009:adverse effects / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000532:radiotherapy*; D009392:Nephrectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D011446:Prospective Studies; D011468:Prostatectomy / Q000009:adverse effects / Q000295:instrumentation*; D011471:Prostatic Neoplasms / Q000601:surgery*; D065287:Robotic Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation*; D013673:Technology Assessment, Biomedical; D052096:Warm Ischemia
keywords: Nephrectomy; Radical prostatectomy; Robotic surgery; Single-port surgery; Single-site surgery; Urology