Robotic kidney transplantation with regional hypothermia: evolution of a novel procedure utilizing the IDEAL guidelines (IDEAL phase 0 and 1).

Menon, Mani; Abaza, Ronney; Sood, Akshay; Ahlawat, Rajesh; Ghani, Khurshid R; Jeong, Wooju; Kher, Vijay; Kumar, Ramesh K; Bhandari, Mahendra

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. DESIGN, SETTING, AND PARTICIPANTS 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. INTERVENTION IDEAL model implementation in the development of RKT with regional hypothermia. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS 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. RESULTS AND LIMITATIONS 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. PATIENT SUMMARY The IDEAL model allows safe introduction of new surgical techniques without compromising patient outcomes.