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腹腔镜阑尾切除术由初级外科医生完成:三维可视化对手术结果的影响。随机多中心临床试验。(LAPSUS 试验)。

Laparoscopic Appendectomy Performed by junior SUrgeonS: impact of 3D visualization on surgical outcome. Randomized multicentre clinical trial. (LAPSUS TRIAL).

机构信息

General Surgery, ASST SPEDALI CIVILI BRESCIA, Montichiari, Italy.

Montichiari, General Surgery, Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Montichiari, Italy.

出版信息

Surg Endosc. 2021 Feb;35(2):710-717. doi: 10.1007/s00464-020-07436-4. Epub 2020 Feb 14.

DOI:10.1007/s00464-020-07436-4
PMID:32060747
Abstract

BACKGROUND

The purpose of this study was to evaluate the effect of 3D visualization applied to laparoscopic appendectomy (LA) performed by young surgeons (YS). We considered both operative features and clinical outcomes, aiming to highlight the benefits that this technology could bring to novice surgeons and their laparoscopic training.

METHODS

All the surgical procedures were performed by residents who had performed less than 20 appendectomies prior to the beginning of the study under the supervision of an expert surgeon. At the time of enrolment patients were randomized into two arms: Experimental arm (EA): laparoscopic appendectomy performed with laparoscopic 3D vision technology. Control arm (CA): laparoscopic appendectomy performed with the "standard" 2D technology. The primary endpoint was to find any statistically significant difference in operative time between the two arms. Differences in conversion rate, intra-operative complications, post-operative complications and surgeons' operative comfort were considered as secondary endpoints.

RESULTS

We randomized 135 patients into the two study arms. The two groups were homogeneous for demographic characteristics, BMI and ASA scores. The characteristics of clinical presentation and anatomical position showed no significant difference. The operative time was longer in the CA (57.5 vs. 49.6 min, p = 0.048, 95% CI). In the subgroup of complicated appendicitis, this trend toward inferior operative time was confirmed without reaching statistical significance (2D = 60 min, 3D = 49.5 min, p = 0.082 95% CI). No intra-operative complications were observed in either group. The conversion rate was 5.6% (4 patients) in the 2D group and 4.6% (3 patients) in 3D group.

CONCLUSION

The utilization of 3D laparoscopy was associated with reduction in operative time without influencing other parameters, in particular without altering the safety profile of the procedure.

摘要

背景

本研究旨在评估 3D 可视化应用于年轻外科医生(YS)进行的腹腔镜阑尾切除术(LA)的效果。我们考虑了手术特点和临床结果,旨在突出这项技术为新手外科医生及其腹腔镜培训带来的好处。

方法

所有手术均由在研究开始前进行少于 20 例阑尾切除术的住院医师在专家外科医生的监督下进行。入组时,患者随机分为两组:实验组(EA):使用腹腔镜 3D 视觉技术进行腹腔镜阑尾切除术。对照组(CA):使用“标准”2D 技术进行腹腔镜阑尾切除术。主要终点是在两组之间找到手术时间的任何统计学显著差异。转换率、术中并发症、术后并发症和外科医生手术舒适度的差异被认为是次要终点。

结果

我们将 135 例患者随机分为两组。两组的人口统计学特征、BMI 和 ASA 评分均相同。临床表现和解剖位置的特征没有明显差异。CA 的手术时间较长(57.5 与 49.6 分钟,p=0.048,95%CI)。在复杂阑尾炎亚组中,这种手术时间较差的趋势得到了证实,但没有达到统计学意义(2D=60 分钟,3D=49.5 分钟,p=0.082,95%CI)。两组均未观察到术中并发症。2D 组的转换率为 5.6%(4 例),3D 组为 4.6%(3 例)。

结论

使用 3D 腹腔镜可缩短手术时间,而不影响其他参数,特别是不改变手术的安全性。

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