title: Robotic kidney transplantation with regional hypothermia: evolution of a novel procedure utilizing the IDEAL guidelines (IDEAL phase 0 and 1).
abstract: BACKGROUND
  Surgical innovation is essential for progress of surgical science, but its implementation comes with potential harms during the learning phase. The Balliol Collaboration has recommended a set of guidelines (Innovation, Development, Exploration, Assessment, Long-term study [IDEAL]) that permit innovation while minimizing complications.
  
  
  OBJECTIVE
  To utilize the IDEAL model of surgical innovation in the development of a novel surgical technique, robotic kidney transplantation (RKT) with regional hypothermia, and describe the process of discovery and development.
  
  
  METHODS
  Phase 0 (simulation) studies included the establishment of techniques for pelvic cooling, graft placement in a robotic prostatectomy model, and simulation of the RKT procedure in a cadaveric model. Phase 1 (innovation) studies began in January 2013 and involved treatment of a highly selective small group of patients (n=7), using the principles utilized in the phase 0 studies, at a tertiary referral center.
  
  
  METHODS
  IDEAL model implementation in the development of RKT with regional hypothermia.
  
  
  METHODS
  For phase 0 studies, the outcomes evaluated included pelvic and body temperature measurements, and technical feasibility assessment. The primary outcome during phase 1 was post-transplant graft function. Other outcomes measured were operative and ischemic times, perioperative complications, and intracorporeal graft surface temperature.
  
  
  CONCLUSIONS
  Phase 0 (simulation phase): Pelvic cooling to 15-20(o)C was achieved reproducibly. Using the surgical approach developed for robotic radical prostatectomy, vascular and ureterovesical anastomoses could be done without redocking the robot. Phase 1 (innovation phase): All patients underwent live-donor RKT in the lithotomy position. All grafts functioned immediately. Mean console, anastomotic, and warm ischemia times were 154 min, 29 min, and 2 min, respectively. One patient was re-explored on postoperative day 1.
  
  
  CONCLUSIONS
  Adherence to the IDEAL guidelines put forth by the Balliol Collaboration provided a practical framework for the establishment of a novel surgical procedure, RKT with regional hypothermia, without exposing the initial patients to unacceptable risk.
  
  
  RESULTS
  The IDEAL model allows safe introduction of new surgical techniques without compromising patient outcomes.
authors.affiliation: Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: Mani
authors.initials: M
authors.lastname: Menon
authors.affiliation: Department of Urology, Ohio State University, Columbus, OH, USA.
authors.forename: Ronney
authors.initials: R
authors.lastname: Abaza
authors.affiliation: Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA. Electronic address: asood1@hfhs.org.
authors.forename: Akshay
authors.initials: A
authors.lastname: Sood
authors.affiliation: Kidney and Urology Institute, Medanta-The Medicity, Gurgaon, India.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Ahlawat
authors.affiliation: Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: Khurshid R
authors.initials: KR
authors.lastname: Ghani
authors.affiliation: Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: Wooju
authors.initials: W
authors.lastname: Jeong
authors.affiliation: Kidney and Urology Institute, Medanta-The Medicity, Gurgaon, India.
authors.forename: Vijay
authors.initials: V
authors.lastname: Kher
authors.affiliation: Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: Ramesh K
authors.initials: RK
authors.lastname: Kumar
authors.affiliation: Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: Mahendra
authors.initials: M
authors.lastname: Bhandari
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D035843:Biomedical Research / Q000592:standards; D001831:Body Temperature; D002102:Cadaver; D005240:Feasibility Studies; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007036:Hypothermia, Induced / Q000379:methods*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000379:methods*; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D012371:Robotics / Q000379:methods*; D052096:Warm Ischemia; D055815:Young Adult
keywords: Hypothermia; IDEAL guidelines; Kidney; Kidney transplantation; Robotics