Open Versus Robot-assisted Kidney Transplantation in Adults with End-stage Kidney Disease (ORAKTx): A Randomised Open-label Trial

Background and objective We investigated whether robot-assisted kidney transplantation (KTx) could reduce short-term surgical complications compared to open KTx. Methods We conducted a randomised, parallel, open-label trial at the Copenhagen University Hospital – Rigshospitalet, Denmark. Adult patients with end-stage kidney disease and no contraindication to robotic surgery, scheduled to undergo living or deceased donor KTx, were randomly assigned to receive either open or robot-assisted surgery. Primary outcomes were the 30-d post-transplant rates of vascular and major surgical complications. All participants who underwent transplantation were analysed according to assigned intervention. Key findings and limitations A total of 54 participants were assigned to robot-assisted KTx and 53 were assigned to open KTx. Fifty-three participants in each arm underwent transplantation and completed follow-up. Major surgical complications occurred in 13 patients (25%) in the open arm and in seven patients (13%) in the robotic arm (risk difference: −11%, 95% confidence interval [CI]: −26 to 3.4, p = 0.2). Vascular complications occurred in 10 patients (19%) in the open arm and in five patients (9.4%) in the robotic arm (risk difference: −9.4%, 95% CI: −23 to 3.7, p = 0.3). Limitations include single-centre design, lack of blinding, and a modest sample size. Conclusions and clinical implications ORAKTx is the first randomised trial to compare robot-assisted KTx with open KTx surgery. Although the primary endpoint was not met, the observed reduction in complications suggests a potentially meaningful decrease in postoperative morbidity with robot-assisted surgery.