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

Methods

Multicentre, non-inferiority, randomised controlled trial.

多中心、非劣效性、随机对照试验。

Five hospitals in China from December 2023 to June 2024.

2023年12月至2024年6月，中国五家医院。

Patients scheduled to undergo radical prostatectomy or partial nephrectomy.

计划接受根治性前列腺切除术或部分肾切除术的患者。

Patients were randomly assigned 1:1 to undergo telesurgery or local surgery.

患者被随机1:1分配接受远程手术或局部手术。

The primary outcome was the probability of success of surgery, determined by the medical team on the basis of pre-established criteria.

主要结果是手术成功的概率，由医疗团队根据预先设定的标准确定。

The pre-specified non-inferiority margin was an absolute reduction in probability of 0.1.

预先设定的非劣效性边界是概率绝对减少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.

与手术和早期恢复相关的临床次要结果有十三个，与医疗团队工作量相关的次要结果有一个。

Four technical secondary outcomes for the surgical system were also explored, including network latency, display latency, frame loss during telesurgery, and system malfunction.

还探索了手术系统的四项技术次要结果，包括网络延迟、显示延迟、远程手术期间的帧丢失以及系统故障。

The participants were followed up at four and six weeks postoperatively for the secondary outcomes of recovery and complications.

参与者在术后四周和六周进行了随访，以评估恢复和并发症的次要结果。

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-treatset.

共有72名参与者被纳入研究，并按1:1的比例随机分配到远程手术组和本地手术组，用于意向治疗集。

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.

远程手术组患者的中位年龄为61.0岁（四分位数范围57.5-68.0岁），本地手术组患者的中位年龄为65.0岁（四分位数范围56.5-70.0岁）。

Telesurgery was not inferior to local surgery in terms of the probability of surgical success in the intention-to-treatpopulation, 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).

在意向治疗人群中，远程手术在手术成功率方面并不逊色于本地手术，考虑到了外科医生的聚类效应（成功率差异为0.02（95%可信区间为-0.03至0.15），贝叶斯后验概率为0.99，表明非劣效性）。

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.

远程手术系统在1000公里至2800公里的距离范围内稳定，平均往返网络延迟为20.1-47.5毫秒，远程手术过程中的帧丢失为0-1.5帧。

Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups.

次要结果包括手术基础数据、并发症、早期恢复、肿瘤学结果以及医疗团队的工作量，在两组之间没有显著差异。

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.

根据0.1的成功概率减少的非劣效性边界，远程手术的可靠性不低于本地机器人手术。

trial_registration

ChiCTR.org ChiCTR2300077721.

ChiCTR.org ChiCTR2300077721。