Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial

摘要

OBJECTIVE: To investigate whether the reliability of telesurgery is non-inferior to that of standard local surgery in patients undergoing urological robotic operations. DESIGN: Multicentre, non-inferiority, randomised controlled trial. SETTING: Five hospitals in China from December 2023 to June 2024. PARTICIPANTS: Patients scheduled to undergo radical prostatectomy or partial nephrectomy. INTERVENTIONS: Patients were randomly assigned 1:1 to undergo telesurgery or local surgery. MAIN OUTCOME MEASURES: The primary outcome was the probability of success of surgery, determined by the medical team on the basis of pre-established criteria. The pre-specified non-inferiority margin was an absolute reduction in probability of 0.1. Thirteen clinical secondary outcomes were associated with the operation and early recovery, and one secondary outcome related to the workload of the medical team. Four technical secondary outcomes for the surgical system were also explored, including network latency, display latency, frame loss during telesurgery, and system malfunction. The participants were followed up at four and six weeks postoperatively for the secondary outcomes of recovery and complications. RESULTS: A total of 72 participants were enrolled in the study and randomised 1:1 to the telesurgery group and the local surgery group for the intention-to-treat set. The median age of patients was 61.0 (interquartile range 57.5-68.0) years in the telesurgery group and 65.0 (56.5-70.0) years in the local surgery group. Telesurgery was not inferior to local surgery in terms of the probability of surgical success in the intention-to-treat population, accounting for clustering by surgeon (success probability difference 0.02 (95% credible interval -0.03 to 0.15) with bayesian posterior probability of 0.99 for non-inferiority). The telesurgery system was stable with a distance from 1000 km to 2800 km, a mean round trip network latency of 20.1-47.5 ms, and frame loss of 0-1.5 per telesurgery. Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups. CONCLUSIONS: The reliability of telesurgery was non-inferior to that of local robotic surgery according to the non-inferiority margin of a 0.1 reduction in success probability. TRIAL REGISTRATION: ChiCTR.org ChiCTR2300077721.