Background: Recent publications suggest that the threshold for validation of the learning curve is 25 procedures. The aim of this study was to evaluate this threshold using another rarely used method, based on a composite quality indicator. Methods: We included all patients from the French medico-administrative database receiving robot-assisted surgery for lung cancer, with a focus on hospitals performing at least 25 procedures over the period 2019–2022. For postoperative complication analysis, we used the Clavien–Dindo classification. We used the sequential probability ratio test to estimate the number of procedures at which a hospital achieved its learning curve. Results: In France, the number of robotic-assisted procedures has risen steadily in the past few years: 195 in 2019 and 1567 in 2022 (overall, 3706 Robot-Assisted surgeries). The total number of patients with Clavien–Dindo classification > II was 833 (24.7%). Among the 28 hospitals performing at least 25 procedures, eight achieved their learning curve with thresholds ranging from 94 to 174 procedures, and the median was 110. Severe complications such as acute respiratory distress syndrome, respiratory failure, heart failure, acute ischemia of the lower limbs, or pulmonary embolism were significantly more frequent in the group of hospitals that did not validate the learning curve threshold. Conclusions: This study suggests that the threshold of 25 procedures may not be sufficient to validate the robot-assisted surgery learning curve in lung cancer surgery. To significantly reduce postoperative complications, a hospital would need to perform 94 to 174 procedures to guarantee patient safety.
背景:近期文献表明,学习曲线验证的阈值设定为25例手术。本研究旨在通过另一种基于复合质量指标的罕见方法,评估该阈值的适用性。方法:我们纳入了法国医疗管理数据库中所有接受机器人辅助肺癌手术的患者,重点关注2019年至2022年间手术量至少达到25例的医院。针对术后并发症分析,我们采用Clavien-Dindo分级系统。通过序贯概率比检验,我们估算了各医院达到学习曲线所需的手术例数。结果:在法国,机器人辅助手术量近年来持续增长:2019年为195例,2022年达1567例(总计3706例机器人辅助手术)。Clavien-Dindo分级>Ⅱ级的患者总数为833例(占比24.7%)。在28家手术量≥25例的医院中,有8家医院达到学习曲线,阈值范围为94至174例,中位数为110例。在未达到学习曲线阈值的医院组中,急性呼吸窘迫综合征、呼吸衰竭、心力衰竭、下肢急性缺血或肺栓塞等严重并发症的发生率显著更高。结论:本研究表明,25例手术的阈值可能不足以验证机器人辅助肺癌手术的学习曲线。为显著降低术后并发症,医院需完成94至174例手术才能确保患者安全。