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腹腔镜与开腹直肠切除术治疗直肠癌的比较:一项随机对照试验的个体患者数据荟萃分析。

Laparoscopic versus open resection for rectal cancer: An individual patient data meta analysis of randomized controlled trials.

机构信息

Yong Loo Lin School of Medicine, National University Singapore, Singapore.

Yong Loo Lin School of Medicine, National University Singapore, Singapore; Biostatistics & Modelling Domain, Saw Swee Hock School of Public Health, National University of Singapore, Singapore.

出版信息

Eur J Surg Oncol. 2022 May;48(5):1133-1143. doi: 10.1016/j.ejso.2021.11.012. Epub 2021 Nov 11.

DOI:10.1016/j.ejso.2021.11.012
PMID:34794842
Abstract

BACKGROUND AND AIMS

The role of laparoscopic rectal cancer resection remains controversial. Thus, we aimed to conduct a one-stage meta-analysis with reconstructed patient-level data using randomized trial data to compare long-term oncologic efficacy of laparoscopic and open surgical resection for rectal cancer.

METHODS

Medline, EMBASE and Scopus were searched for articles comparing laparoscopic with open surgery for rectal cancer. Primary outcome was disease free survival (DFS) while secondary outcome was overall survival (OS). One-stage meta-analysis was conducted using patient-level survival data reconstructed from Kaplan-Meier curves with Web Plot Digitizer. Shared-frailty and stratified Cox models were fitted to compare survival endpoints.

RESULTS

Seven randomized trials involving 1767 laparoscopic and 1293 open resections for rectal cancer were included. There were no significant differences between both groups for DFS and OS with respective hazard ratio estimates of 0.91 (95% CI: 0.78-1.06, p = 0.241) and 0.86 (95% CI:0.73-1.02, p = 0.090). Sensitivity analysis for non-metastatic patients and patients with mid and lower rectal cancer showed no significant differences in OS and DFS between both surgical approaches. In the laparoscopic arm, improved DFS was noted for stage II (HR: 0.73, 95% CI:0.54-0.98, p = 0.036) and stage III rectal cancers (HR: 0.74, 95% CI:0.55-0.99, p = 0.041).

CONCLUSIONS

This meta-analysis concludes that laparoscopic rectal cancer resection does not compromise long-term oncologic outcomes compared with open surgery with potential survival benefits for a minimal access approach in patients with stage II and III rectal cancer.

摘要

背景与目的

腹腔镜直肠癌切除术的作用仍存在争议。因此,我们旨在通过对随机试验数据进行重建患者水平数据的单阶段荟萃分析,比较腹腔镜与开放手术治疗直肠癌的长期肿瘤学疗效。

方法

检索 Medline、EMBASE 和 Scopus 数据库,以比较腹腔镜与开腹手术治疗直肠癌的文章。主要结局是无病生存率(DFS),次要结局是总生存率(OS)。使用 Web Plot Digitizer 从 Kaplan-Meier 曲线重建患者水平生存数据进行单阶段荟萃分析。采用共享脆弱性和分层 Cox 模型比较生存终点。

结果

纳入了 7 项涉及 1767 例腹腔镜和 1293 例开腹直肠癌切除术的随机试验。两组在 DFS 和 OS 方面无显著差异,相应的危险比估计值分别为 0.91(95%CI:0.78-1.06,p=0.241)和 0.86(95%CI:0.73-1.02,p=0.090)。对非转移性患者和中低位直肠癌患者的敏感性分析显示,两种手术方法在 OS 和 DFS 方面无显著差异。在腹腔镜组中,Ⅱ期(HR:0.73,95%CI:0.54-0.98,p=0.036)和Ⅲ期直肠癌(HR:0.74,95%CI:0.55-0.99,p=0.041)患者的 DFS 得到改善。

结论

这项荟萃分析得出的结论是,与开放手术相比,腹腔镜直肠癌切除术并不影响长期肿瘤学结果,对于Ⅱ期和Ⅲ期直肠癌患者,微创方法可能具有生存获益。

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