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机器人辅助部分肾切除术的 ERUS 课程:结构定义和初步临床验证。

The ERUS Curriculum for Robot-assisted Partial Nephrectomy: Structure Definition and Pilot Clinical Validation.

机构信息

Department of Urology, Division of Oncology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; ORSI Academy, Melle, Belgium; Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium.

Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium.

出版信息

Eur Urol. 2019 Jun;75(6):1023-1031. doi: 10.1016/j.eururo.2019.02.031. Epub 2019 Apr 9.

Abstract

BACKGROUND

No validated training program for robot-assisted partial nephrectomy (RAPN) exists.

OBJECTIVE

To define the structure and provide a pilot clinical validation of a curriculum for robot-assisted partial nephrectomy (RAPN).

DESIGN, SETTING, AND PARTICIPANTS: A modified Delphi consensus methodology involving 27 experts defined curriculum structure. One trainee completed the curriculum under the mentorship of an expert. A total of 40 patients treated with curriculum RAPN (cRAPN) were compared with 160 patients treated with standard of care (sRAPN).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

To define curriculum structure, consensus was defined as ≥90% expert agreement. To investigate curriculum safety, perioperative morbidity, renal function, and pathologic outcomes were evaluated. To investigate curriculum efficacy, RAPN steps and modules attempted and completed by the trainee were evaluated. Propensity score matching identified comparable cRAPN and sRAPN cases. Mann-Whitney U test, chi-square test, and linear regression were used to investigate the impact of the curriculum on patient's outcome and the impact of trainee's experience on surgical independence.

RESULTS AND LIMITATIONS

Consensus-based key statements defined curriculum structure. No difference was recorded between cRAPN and sRAPN with respect to intraoperative or overall and grade-specific postoperative complications, blood loss, ischemia time, postoperative estimated glomerular filtration rate, and positive surgical margins (all p>0.05). Conversely, operative time was longer after cRAPN (p<0.0001). The trainee completed all phases of the curriculum and the trainee's experience was associated with more steps attempted/completed and increasing complexity of module attempted/completed (all p<0.0001). The limitations of the study are the enrolment of a single trainee at a single institution and the small sample size. Accordingly, the large confidence intervals observed cannot exclude inferior outcomes in case of cRAPN and further study is required to confirm safety.

CONCLUSIONS

The European Association of Urology (EAU) Robotic Urology Section (ERUS) curriculum for RAPN can protect patients from suboptimal outcome during the learning curve of the surgeon and can aid surgeons willing to start an RAPN program.

PATIENT SUMMARY

Patients should be aware that structured training programs can reduce the risk of suboptimal outcome due to the learning curve of the surgeon.

摘要

背景

目前尚无针对机器人辅助部分肾切除术(RAPN)的已验证培训计划。

目的

定义机器人辅助部分肾切除术(RAPN)课程的结构并进行初步临床验证。

设计、地点和参与者:采用改良 Delphi 共识方法,涉及 27 名专家,确定了课程结构。一名学员在专家的指导下完成了课程。对接受课程式机器人辅助部分肾切除术(cRAPN)治疗的 40 例患者与接受标准护理(sRAPN)治疗的 160 例患者进行了比较。

观察指标和统计分析

为了确定课程结构,将专家一致同意率≥90%定义为达成共识。为了研究课程的安全性,评估了围手术期发病率、肾功能和病理结果。为了研究课程的疗效,评估了学员尝试和完成的 RAPN 步骤和模块。采用倾向评分匹配确定可比的 cRAPN 和 sRAPN 病例。采用 Mann-Whitney U 检验、卡方检验和线性回归分析课程对患者结局的影响以及学员经验对手术独立性的影响。

结果和局限性

基于共识的关键表述确定了课程结构。cRAPN 和 sRAPN 在术中或总并发症以及特定分级术后并发症、出血量、缺血时间、术后估计肾小球滤过率和阳性手术切缘(均 p>0.05)方面无差异。相反,cRAPN 的手术时间更长(p<0.0001)。学员完成了课程的所有阶段,学员的经验与尝试/完成的步骤数量增加以及尝试/完成的模块复杂性增加有关(均 p<0.0001)。研究的局限性在于仅在单个机构招收了一名学员,且样本量较小。因此,观察到的置信区间较大不能排除 cRAPN 结果较差的情况,需要进一步研究来确认安全性。

结论

欧洲泌尿外科学会(EAU)机器人泌尿外科分会(ERUS)RAPN 课程可保护患者免受术者学习曲线不佳的影响,并可帮助愿意开展 RAPN 项目的术者。

患者总结

患者应该知道,结构化培训计划可以降低由于术者学习曲线导致的结果不佳的风险。

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