Kwon Sun-Ho, Joo Yea-Il, Kim Seon Hahn, Lee Dae Ho, Baek Jeong-Heum, Chung Soon Sup, Shin Ji-Yeon, Eun Chang Soo, Kim Nam Kyu
Division for New Health Technology Assessment, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.
TaTME Assessment Committee, National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.
Ann Surg Treat Res. 2021 Sep;101(3):167-180. doi: 10.4174/astr.2021.101.3.167. Epub 2021 Aug 31.
Under the South Korea's unique health insurance structure, any new surgical technology must be evaluated first by the government in order to consider whether that particular technology can be applied to patients for further clinical trials as categorized as 'New Health Technology,' then potentially covered by the insurance sometime later. The aim of this meta-analysis was to assess the safety and efficacy of transanal total mesorectal excision (TaTME) for rectal cancer, activated by the National Evidence-based Healthcare Collaborating Agency (NECA) TaTME committee.
We systematically searched Ovid-MEDLINE, Ovid-Embase, Cochrane, and Korean databases (from their inception until August 31, 2019) for studies published that compare TaTME with laparoscopic total mesorectal excision (LaTME). End-points included perioperative and pathological outcomes.
Sixteen cohort studies (7 for case-matched studies) were identified, comprising 1,923 patients (938 TaTMEs and 985 LaTMEs). Regarding perioperative outcomes, the conversion rate was significantly lower in TaTME (risk ratio, 0.19; 95% confidence interval, 0.11-0.34; P < 0.001); whereas other perioperative outcomes were similar to LaTME. There were no statistically significant differences in pathological results between the 2 procedures.
Our meta-analysis showed comparable results in preoperative and pathologic outcomes between TaTME and LaTME, and indicated the benefit of TaTME with low conversion. Extensive evaluations of well-designed, multicenter randomized controlled trials are required to come to unequivocal conclusions, but the results showed that TaTME is a potentially beneficial technique in some specific cases. This meta-analysis suggests that TaTME can be performed for rectal cancer patients as a 'New Health Technology' endorsed by NECA in South Korea.
在韩国独特的医疗保险结构下,任何新的外科技术都必须首先由政府进行评估,以确定该特定技术是否可应用于患者进行进一步的临床试验,并被归类为“新医疗技术”,随后有可能在一段时间后被纳入保险覆盖范围。本荟萃分析的目的是评估经肛门全直肠系膜切除术(TaTME)治疗直肠癌的安全性和有效性,该研究由韩国国家循证医疗合作机构(NECA)TaTME委员会发起。
我们系统检索了Ovid-MEDLINE、Ovid-Embase、Cochrane和韩国数据库(从建库至2019年8月31日),以查找比较TaTME与腹腔镜全直肠系膜切除术(LaTME)的已发表研究。终点指标包括围手术期和病理结果。
共纳入16项队列研究(7项病例对照研究),包括1923例患者(938例行TaTME,985例行LaTME)。关于围手术期结果,TaTME的中转率显著更低(风险比,0.19;95%置信区间,0.11 - 0.34;P < 0.001);而其他围手术期结果与LaTME相似。两种手术的病理结果无统计学显著差异。
我们的荟萃分析显示,TaTME与LaTME在术前和病理结果方面具有可比结果,并表明TaTME具有低中转率的优势。需要进行精心设计的多中心随机对照试验的广泛评估才能得出明确结论,但结果表明TaTME在某些特定情况下是一种潜在有益的技术。该荟萃分析表明,TaTME可作为韩国NECA认可的“新医疗技术”用于直肠癌患者。