[论文解读] Intraoperative time out to promote the implementation of the critical view of safety in laparoscopic cholecystectomy: a video-based assessment of 343 procedures

Pietro Mascagni, María Rita Rodríguez‐Luna+8 more|arXiv (Cornell University)|Apr 6, 2021

Gallbladder and Bile Duct Disorders参考文献 49被引用 34

一句话总结

本研究评估了在腹腔镜胆囊切除术中实施5秒术中暂停以改善安全关键视图（CVS）的效果。通过对343例手术的视频评估发现，该干预措施使CVS达成率从15.9%提高至44.1%，显著提升了安全意识和手术一致性，且未增加发病率。

ABSTRACT

Background: The critical view of safety (CVS) is poorly adopted in surgical practices although it is ubiquitously recommended to prevent major bile duct injuries during laparoscopic cholecystectomy (LC). This study aims to determine whether performing a short intraoperative time out can improve CVS implementation. Methods: Surgeons performing LCs at an academic centre were invited to perform a 5-second long time out to verify CVS before dividing the cystic duct (5-second rule). The primary endpoint was to compare the rate of CVS achievement between LCs performed in the year before and the year after the 5-second rule. The CVS achievement rate was computed using the mediated video-based assessment of two independent reviewers. Clinical outcomes, LC workflows, and postoperative reports were also compared. Results: Three hundred and forty-three (171 before and 172 after the 5-second rule) of the 381 LCs performed over the 2-year study were analysed. After the implementation of the 5-second rule, the rate of CVS achievement increased significantly (15.9 vs 44.1 %; P<0.001) as well as the rate of bailout procedures (8.2 vs 15.7 %; P=0.045), the median time to clip the cystic duct or artery (17:26 [interquartile range: 16:46] vs 23:12 [17:16] minutes; P=0.007), and the rate of postoperative CVS reporting (1.3 vs 28.8 %; P<0.001). Morbidity was comparable (1.75 vs 2.33 % before and after the 5-second rule respectively; P=0.685). Conclusion: Performing a short intraoperative time out improves CVS implementation during LC. Systematic intraoperative cognitive aids should be studied to sustain the uptake of guidelines.

研究动机与目标

• 评估简短术中暂停是否能提高腹腔镜胆囊切除术中对安全关键视图（CVS）的依从性。
• 评估5秒规则对CVS达成率、手术流程及术后CVS报告的影响。
• 确定该干预是否能增强安全文化并降低胆管损伤风险。
• 探讨认知辅助工具在提升外科实践中指南采纳率中的作用。

提出的方法

• 采用前后对照的质量改进研究设计，比较实施5秒规则前后各171例和172例腹腔镜胆囊切除术。
• 指导外科医生在结扎胆囊管前进行5秒暂停，以确认CVS标准：两条结构（胆囊管和动脉）、胆囊肝三角区充分解剖分离，以及胆囊与胆囊床的分离。
• 通过两名独立评审员使用经验证的二元方法进行视频基评估（VBA），在意见不一致时由第三位专家进行调解。
• 主要结局为CVS达成率；次要结局包括手术时间、补救性操作、术中胆道造影使用率及术后CVS报告。
• 使用Cohen’s kappa检验评估评分者间一致性，分类变量的统计比较采用Fisher精确检验。
• 所有数据均来自电子病历和视频标注，未进行术中现场观察。

实验结果

研究问题

• RQ1 实施5秒术中暂停是否能提高腹腔镜胆囊切除术中安全关键视图（CVS）达成率？
• RQ2 5秒规则对手术流程（包括夹闭时间及补救性操作频率）有何影响？
• RQ3 该干预在多大程度上改善了术后CVS状态的报告？
• RQ4 5秒规则是否影响主要胆管损伤发生率或总体发病率？
• RQ5 该暂停对外科医生在胆囊切除术中安全原则的认知与应用有何影响？

主要发现

• 安全关键视图（CVS）达成率从实施5秒规则前的15.9%显著提高至44.1%（p < 0.001）。
• 夹闭胆囊管或动脉的中位时间从17:26分钟（IQR: 16:46）延长至23:12分钟（IQR: 17:16），表明解剖操作更加谨慎。
• 补救性操作率从8.2%上升至15.7%，更频繁地采用胆囊底部优先切除法而非次全胆囊切除法。
• 术后CVS报告率从1.3%大幅提升至28.8%，表明记录质量与意识均有所提高。
• 两组间发病率相当（1.75% vs. 2.33%，p = 0.685），表明患者结局未受负面影响。
• CVS评估的评分者间一致性近乎完美（Cohen’s kappa > 0.90），证实了视频基评估方法的可靠性。