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机器人与腹腔镜手术治疗中低位直肠癌的随机临床试验的荟萃分析。

Meta-analysis of randomized clinical trials comparing robotic versus laparoscopic surgery for mid-low rectal cancers.

机构信息

Department of gynecology and pelvic surgery, CHU de Clermont-Ferrand, Clermont-Ferrand, France.

Digestive surgery department, CHU de Clermont-Ferrand, Clermont-Ferrand, France.

出版信息

J Visc Surg. 2024 Apr;161(2):76-89. doi: 10.1016/j.jviscsurg.2024.01.004. Epub 2024 Feb 13.

Abstract

INTRODUCTION

Robotic surgery (RS) is experiencing major development, particularly in the context of rectal cancer. The aim of this meta-analysis was to summarize data from the literature, focusing specifically on the safety and effectiveness of robotic surgery in mid-low rectal cancers, based on the hypothesis that that robotic surgery can find its most rational indication in this anatomical location.

METHOD

The meta-analysis was conducted according to the PRISMA 2000 recommendations, including all randomized trials that compared robotic surgery versus laparoscopic surgery (LS) that were found in the Medline-PICO, Cochrane Database, Scopus and Google databases. Data were extracted independently by two reviewers. The risk of bias was analyzed according to the Cochrane Handbook method and the certainty of the evidence according to the GRADE method. The analysis was carried out with R software Version 4.2-3 using the Package for Meta-Analysis "meta" version 6.5-0.

RESULTS

Eight randomized trials were included (with a total of 2342 patients), including four that focused specifically on mid-low rectal cancer (n=1,734 patients). No statistically significant difference was found for overall morbidity, intra-operative morbidity, anastomotic leakage, post-operative mortality, quality of mesorectal specimen, and resection margins. The main differences identified were a lower conversion rate for RS (RR=0.48 [0.24-0.95], p=0.04, I=0%), and a longer operative time for RS (mean difference=39.11min [9.39-68.83], p<0.01, I=96%). The other differences had no real clinical relevance, i.e., resumption of flatus passage (5hours earlier after RS), and lymph node dissection (one more lymph node for LS).

CONCLUSION

This meta-analysis does not confirm the initial hypothesis and does not show a statistically significant or clinically relevant benefit of RS compared to LS for mid-low rectal cancer.

摘要

简介

机器人手术(RS)正在经历重大发展,特别是在直肠癌的背景下。本荟萃分析的目的是根据假设总结文献中的数据,特别关注中低位直肠癌机器人手术的安全性和有效性,即机器人手术在这个解剖位置可以找到最合理的适应证。

方法

根据 PRISMA 2000 建议进行荟萃分析,包括在 Medline-PICO、Cochrane 数据库、Scopus 和 Google 数据库中找到的所有比较机器人手术与腹腔镜手术(LS)的随机试验。数据由两名审阅者独立提取。根据 Cochrane 手册方法分析偏倚风险,根据 GRADE 方法评估证据确定性。使用 R 软件版本 4.2-3 并使用“meta”版本 6.5-0 的“meta”包进行分析。

结果

纳入了 8 项随机试验(共 2342 例患者),其中 4 项专门针对中低位直肠癌(n=1734 例)。总体发病率、术中发病率、吻合口漏、术后死亡率、中直肠标本质量和切缘无统计学差异。确定的主要差异是 RS 的转换率较低(RR=0.48 [0.24-0.95],p=0.04,I=0%),以及 RS 的手术时间较长(平均差异=39.11min [9.39-68.83],p<0.01,I=96%)。其他差异没有实际的临床意义,即 RS 后排气恢复(早 5 小时)和淋巴结清扫(LS 多一个淋巴结)。

结论

本荟萃分析不支持最初的假设,并且与 LS 相比,RS 对中低位直肠癌的安全性和有效性没有统计学意义或临床意义上的优势。

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