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.