Robotic Kidney Transplantation with Regional Hypothermia: Evolution of a Novel Procedure Utilizing the IDEAL Guidelines (IDEAL Phase 0 and 1)

Abstract

BackgroundSurgical 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. ObjectiveTo 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. Design, setting, and participantsPhase 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. InterventionIDEAL model implementation in the development of RKT with regional hypothermia. Outcome measurements and statistical analysisFor 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. Results and limitationsPhase 0 (simulation phase): Pelvic cooling to 15–20oC 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 154min, 29min, and 2min, respectively. One patient was re-explored on postoperative day 1. ConclusionsAdherence 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. Patient summaryThe IDEAL model allows safe introduction of new surgical techniques without compromising patient outcomes.