Supplementary Material for: Learning Curve for Endoscopic Combined Intra-Renal Surgery Using Vacuum-Assisted Device

Introduction: The aim of the study was to provide data related to endoscopic combined intra-renal surgery learning curve using minimally invasive techniques with vacuum-assisted devices. Minimal data exist on the learning curve for these techniques. Methods: We conducted a prospective study monitoring the training of a mentored surgeon learning ECIRS with vacuum assistance. We use varied parameters for improvements. After collection of peri-operative data, tendency lines and CUSUM analysis were used to investigate the learning curves. Results: 111 patients have been included. Guy’s Stone Score 3 and 4 stones 51.3% of all cases. The mostly used percutaneous sheath was 16 Fr (87.3%). SFR was 78.4%. 52.3% patients were tubeless, and 38.7% achieved trifecta. High-degree complication rate was 3.6%. Operative time improved after 72 cases. We observed a decrease of complications throughout the case series, with improvement after 17 cases. In terms of trifecta, proficiency was reached after 53 cases. Proficiency seems achievable in a limited number of procedures, but results did not plateau. Higher number of cases might be necessary for excellence. Discussion: A surgeon learning ECIRS with vacuum assistance can obtain proficiency in 17–50 cases. The number of procedures required for excellence remains unclear. Exclusion of more complex cases might positively affect the training, reducing unnecessary complications.

引言：本研究旨在提供采用真空辅助器械的微创技术开展内镜联合肾内手术（Endoscopic Combined Intra-Renal Surgery, ECIRS）的学习曲线相关数据。目前针对此类技术的学习曲线相关研究数据较为匮乏。
方法：本研究为前瞻性研究，对一名在导师指导下学习真空辅助内镜联合肾内手术的外科医师的培训过程进行监测。本研究采用多维度参数以评估手术质量提升情况。在收集围手术期数据后，通过趋势线分析与累积和（CUSUM）分析来探究该手术的学习曲线。
结果：本研究共纳入111例患者。其中盖伊结石评分3分及4分的结石病例占总病例数的51.3%。临床中最常用的经皮鞘管尺寸为16 Fr（占比87.3%）。结石清除率（Stone-Free Rate, SFR）为78.4%。52.3%的患者接受了无管化手术，38.7%的患者达成三达标结局。严重并发症发生率为3.6%。手术时长在完成72例手术后出现显著改善。本研究序列中可见并发症发生率随病例数增加逐渐降低，在完成17例手术后即出现并发症控制情况的改善。就三达标结局而言，术者在完成53例手术后达到操作熟练度。该手术的操作熟练度可通过有限的手术例数达成，但疗效未进入平台期，若要实现卓越疗效，可能需要完成更多的手术病例。
讨论：学习真空辅助内镜联合肾内手术的外科医师可通过17~50例手术病例达成操作熟练度。但达成卓越疗效所需的手术例数仍不明确。排除高复杂程度病例可能对培训产生积极影响，减少不必要的并发症发生。