Importance Two large randomized clinical trials (RCTs) found that laparoscopic surgery failed to yield noninferior pathologic outcomes compared with open surgery for patients with rectal cancer. The results raised concerns regarding the effectiveness of the laparoscopic approach for patients with rectal cancer. Objective To compare the long-term oncologic outcomes of laparoscopic and open surgery for patients with rectal cancer. Data Sources PubMed, Web of Science, Embase, and Cochrane Central Register of Controlled Trials were searched from database inception to August 13, 2021. Studies published in English were retrieved. Study Selection The meta-analysis included RCTs that compared laparoscopic surgery with open surgery for patients with rectal cancer and reported the outcome of disease-free survival (DFS) or overall survival (OS). The following exclusion criteria were used: (1) non-RCTs, (2) studies without long-term survival outcomes of interest, and (3) studies that did not report Kaplan-Meier survival curves. Data Extraction and Synthesis This meta-analysis was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline for individual participant data development groups. Individual participant data on DFS and OS were extracted from the published Kaplan-Meier survival curves. One-stage and 2-stage meta-analyses were performed. Main Outcomes and Measures Meta-analyses were conducted for DFS and OS. Hazard ratios (HRs) were used as effective measures. Results Of 8471 records screened, 10 articles with 12 RCTs and 3709 participants were selected. The reconstructed survival curves for the combined population showed that the 5-year estimated DFS rates were 72.2% (95% CI, 69.4%-74.8%) for the laparoscopic group and 70.1% (95% CI, 67.0%-73.0%) for the open surgery group, and the 5-year estimated OS rates were 76.2% (95% CI, 73.8%-78.5%) for the laparoscopic group and 72.7% (95% CI, 69.8%-75.3%) for open surgery group. In 1-stage meta-analyses, DFS had a nonsignificant HR of 0.92 (95% CI, 0.80-1.06; P = .26), which suggested that DFS in the laparoscopic and open surgery groups was comparable; however, OS was significantly better in the laparoscopic group (HR, 0.85; 95% CI, 0.74-0.97; P = .02). The results were confirmed by 2-stage meta-analyses and were validated by sensitivity analysis with large RCTs. Conclusions and Relevance A similar DFS but significantly better OS were found for patients who have undergone laparoscopic surgery compared with open surgery for rectal cancer. These findings address concerns regarding the effectiveness of laparoscopic surgery and support the routine use of laparoscopic surgery for patients with rectal cancer.

中文翻译：

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接受腹腔镜与开腹手术的直肠癌成人患者的生存率比较：一项荟萃分析。

重要性 两项大型随机临床试验 (RCT) 发现，与直肠癌患者的开腹手术相比，腹腔镜手术未能产生非劣效的病理结果。结果引起了人们对腹腔镜方法对直肠癌患者的有效性的担忧。目的比较腹腔镜和开腹手术治疗直肠癌患者的远期肿瘤学结果。数据来源 PubMed、Web of Science、Embase 和 Cochrane Central Register of Controlled Trials 从数据库开始到 2021 年 8 月 13 日进行了检索。检索了以英文发表的研究。研究选择 该荟萃分析包括比较腹腔镜手术与直肠癌患者开腹手术的随机对照试验，并报告了无病生存期 (DFS) 或总生存期 (OS) 的结果。使用了以下排除标准：(1) 非 RCT，(2) 没有感兴趣的长期生存结果的研究，以及 (3) 没有报告 Kaplan-Meier 生存曲线的研究。数据提取和综合 该荟萃分析是根据系统评价的首选报告项目和个体参与者数据开发组的荟萃分析报告指南进行的。DFS 和 OS 的个体参与者数据是从已发表的 Kaplan-Meier 生存曲线中提取的。进行了一阶段和二阶段的荟萃分析。主要结果和措施 对 DFS 和 OS 进行了荟萃分析。危险比（HRs）被用作有效措施。结果 筛选出 8471 篇文献，筛选出 10 篇文章，12 篇 RCT，3709 名受试者。合并人群的重建生存曲线显示，腹腔镜组的 5 年估计 DFS 率为 72.2%（95% CI，69.4%-74.8%），腹腔镜组为 70.1%（95% CI，67.0%-73.0%）。腹腔镜组和开放手术组的 5 年估计 OS 率为 76.2%（95% CI，73.8%-78.5%）和 72.7%（95% CI，69.8%-75.3%）。在 1 阶段荟萃分析中，DFS 的 HR 为 0.92（95% CI，0.80-1.06；P = 0.26），这表明腹腔镜组和开放手术组的 DFS 具有可比性；然而，腹腔镜组的 OS 明显更好（HR，0.85；95% CI，0.74-0.97；P = .02）。结果通过两阶段荟萃分析得到证实，并通过大型随机对照试验的敏感性分析得到验证。结论和相关性 与直肠癌开腹手术相比，接受腹腔镜手术的患者的 DFS 相似，但 OS 明显更好。这些发现解决了对腹腔镜手术有效性的担忧，并支持对直肠癌患者常规使用腹腔镜手术。