Data and statistical codes for: Reliability of urological telesurgery compared to local surgery: A multicenter, randomised controlled trial

This multicenter, non-inferiority randomized controlled trial investigated whether telesurgery is as reliable as standard local surgery for patients undergoing urological robotic operations, using a prespecified non-inferiority margin of a 0.1 absolute reduction in surgical success probability. Conducted at five hospitals in China from December to June, the study enrolled patients scheduled for radical prostatectomy or partial nephrectomy and randomly assigned them 1:1 to telesurgery or local surgery. The primary outcome was surgical success probability, assessed by the medical team based on predefined criteria, alongside 13 clinical secondary outcomes related to the operation and early recovery, one secondary outcome assessing medical team workload, and four technical secondary outcomes evaluating network latency, display latency, frame loss, and system malfunction; participants were followed at 4 and 6 weeks postoperatively. A total of 72 participants were included in the intention-to-treat analysis, with mean (SD) ages of 61.0 years (57.5–68.0) in the telesurgery group and 65.0 years (56.5–70.0) in the local surgery group. Telesurgery was found to be non-inferior to local surgery with respect to surgical success probability after accounting for surgeon clustering (success probability difference: 0.02 [−0.03 to 0.15]; Bayesian posterior probability = 0.99 for non-inferiority). The telesurgery system demonstrated stable performance across distances of 1000–2800 km, with mean round-trip latencies of 20.1–47.5 ms and frame loss of 0–1.5 per procedure, and secondary outcomes—including operative metrics, complications, early recovery, oncologic results, and medical team workload—showed no substantial differences between groups. Overall, telesurgery demonstrated reliability that was non-inferior to local robotic surgery, meeting the prespecified non-inferiority margin, and the trial was registered under ChiCTR.org Identifier ChiCTR2300077721.