Hoshino Nobuaki, Fukui Yudai, Hida Koya, Obama Kazutaka
Department of Surgery Kyoto University Graduate School of Medicine Kyoto Japan.
Ann Gastroenterol Surg. 2020 Nov 21;5(2):183-193. doi: 10.1002/ags3.12409. eCollection 2021 Mar.
Randomized controlled trials (RCT) are the gold standard in surgical research, and case-matched studies, such as studies with propensity score matching, are expected to serve as an alternative to RCT. Both study designs have been used to investigate the potential superiority of laparoscopic surgery to open surgery for rectal cancer, but it remains unclear whether there are any differences in the findings obtained using these study designs. We aimed to examine similarities and differences between findings from different study designs regarding laparoscopic surgery for rectal cancer.
Systematic review and meta-analyses. A comprehensive literature search was conducted using PubMed, Scopus, and Cochrane. RCT, case-matched studies, and cohort studies comparing laparoscopic low anterior resection and open low anterior resection for rectal cancer were included. In total, 8 short-term outcomes and 3 long-term outcomes were assessed. Meta-analysis was conducted stratified by study design using a random-effects model.
Thirty-five studies were included in this review. Findings did not differ between RCT and case-matched studies for most outcomes. However, the estimated treatment effect was largest in cohort studies, intermediate in case-matched studies, and smallest in RCT for overall postoperative complications and 3-year local recurrence.
Findings from case-matched studies were similar to those from RCT in laparoscopic low anterior resection for rectal cancer. However, findings from case-matched studies were sometimes intermediate between those of RCT and unadjusted cohort studies, and case-matched studies and cohort studies have a potential to overestimate the treatment effect compared with RCT.
随机对照试验(RCT)是外科研究的金标准,而病例匹配研究,如倾向得分匹配研究,有望作为RCT的替代方法。这两种研究设计都已用于探究腹腔镜手术相对于直肠癌开放手术的潜在优势,但使用这些研究设计所获得的结果是否存在差异仍不明确。我们旨在研究不同研究设计关于直肠癌腹腔镜手术的结果之间的异同。
系统评价和荟萃分析。使用PubMed、Scopus和Cochrane进行全面的文献检索。纳入比较腹腔镜低位前切除术和开放低位前切除术治疗直肠癌的随机对照试验、病例匹配研究和队列研究。总共评估了8项短期结局和3项长期结局。使用随机效应模型按研究设计进行分层荟萃分析。
本综述纳入了35项研究。对于大多数结局,随机对照试验和病例匹配研究的结果没有差异。然而,对于总体术后并发症和3年局部复发,队列研究中估计的治疗效果最大,病例匹配研究居中,随机对照试验最小。
在直肠癌腹腔镜低位前切除术中,病例匹配研究的结果与随机对照试验相似。然而,病例匹配研究的结果有时介于随机对照试验和未调整队列研究之间,并且与随机对照试验相比,病例匹配研究和队列研究有可能高估治疗效果。