Open-label randomised clinical trial investigating whether Robot-Assisted Kidney Transplantation can reduce surgical complications compared to Open Kidney Transplantation (ORAKTx): Study protocol for a randomised clinical trial

Abstract Background: Kidney transplantation is the ultimate treatment for end-stage kidney disease. Function of the kidney graft is not only dependent on medical factors but also a complication-free surgical procedure. In the event of major surgical complications, the kidney graft is potentially lost and the patient will return to the waiting list which may be long. To optimise peri-operative care and reduce complications, robot-assisted kidney transplantation (RAKT) has been introduced as an alternative to open kidney transplantation (OKT), but to our knowledge no randomised clinical trials are comparing RAKT to OKT. We will explore whether robot-assisted surgery can reduce 30-day surgical complications compared to open surgery in kidney transplantation. Methods: This a single-site, open-label, randomised clinical trial comparing RAKT to OKT. Participants are adult recipients of kidney transplantation and all participants are recruited from Copenhagen University Hospital – Rigshospitalet, Denmark. The study plans to include 106 participants who will be randomised in a 1:1 manner between OKT and RAKT. Primary outcomes are vascular- and major surgical complications at 30 days post-operatively. Participants will be followed for two years to evaluate secondary outcomes including recovery, late complications and kidney graft function. This is designed as a superiority trial and planned analyses are as intention-to-treat. Discussion: Studies indicate RAKT can reduce several surgical complications, but the lack of RCTs limits the extrapolation of these results to justify the replacement of an open approach with a robot-assisted one. Ultimately, the introduction of new surgical techniques should be as vigorously tested as any other new treatments. However, reducing surgical complications that compromise graft viability could lead to improved patient care and survival. Trial registration: The trial was prospectively registered on February 15th 2023 on clinicaltrials.gov with NCT-identifier 05730257.