Telesurgery was noninferior to standard local robotic surgery for urologic procedures in a multicenter randomized clinical trial, with a posterior probability of noninferiority of 0.99 and no clinically meaningful differences in perioperative or early recovery outcomes.
For the trial, published in BMJ, Ye Wang, MD, and colleagues at multiple centers in China conducted the first randomized controlled trial comparing the reliability of telesurgery with local robotic surgery. Seventy-two patients scheduled for radical prostatectomy or partial nephrectomy at five Chinese hospitals were randomized 1:1 to telesurgery or local robotic surgery between December 2023 and June 2024.
The primary endpoint was the probability of surgical success, defined as completion according to plan, no injury to major vessels or adjacent organs, no conversion (including from telesurgery to local robotic surgery), and no postponement due to system malfunction. The noninferiority margin was set at an absolute reduction in success probability of 0.1. Analyses used a Bayesian mixed-effects logistic regression model accounting for clustering by surgeon.
In the intention-to-treat population, surgical success occurred in 100% of telesurgery cases versus 94% of local cases, meeting the prespecified criteria for noninferiority. In the per-protocol analysis, success rates were 100% and 97%, respectively.
Only one failure occurred in the local group owing to robotic system malfunction; no failures occurred in the telesurgery group.
Operative time, warm ischemia time, and estimated blood loss did not differ significantly between groups. Median operative time was 152 minutes with telesurgery and 135 minutes with local surgery.
Postoperative hospital stay was similar (6.0 vs 5.5 days). One Clavien-Dindo grade III complication, unrelated to surgery, occurred in the telesurgery group. No reoperations, readmissions, transfusions, or deaths were reported.
Early recovery metrics, including quality-of-recovery scores, functional testing, and prostate cancer–specific outcomes, were comparable. Positive surgical margins were observed in 3% of telesurgery cases and 16% of local cases, although the study was not powered for oncologic endpoints.
Surgeon workload, assessed by the NASA Task Load Index, was lower in the telesurgery group (median 29 vs 48), while assistant and nursing workload did not differ.
Technical monitoring showed stable system performance across distances of 1,000 to 2,800 km, with mean round-trip network latency ranging from 20 to 47.5 milliseconds and minimal frame loss.
The investigators noted certain limitations of the study, including its small sample size, a 12.5% withdrawal rate, the empiric selection of the noninferiority margin in the absence of prior randomized data, and that masking of surgeons was not feasible.
The study was supported by grants from the Science Foundation of China, the Noncommunicable Chronic Diseases-National Science and Technology Major Project, and the Beijing Natural Science Foundation. The surgical robots were provided by EdgeMedical.
Source: BMJ
