Incidence and risk factors of anastomotic leak after transanal total mesorectal excision in China: a retrospective analysis based on national database

Abstract

<p> <strong>Objective:</strong> Transanal total mesorectal excision (taTME) was a very hot topic in the first few years since its appearance, but now more introspections and controversies on this procedure have emerged. One of the reasons why the Norwegian Ministry of Health stopped taTME was the high incidence of postoperative anastomotic leak. In current study, the incidence and risk factors of anastomotic leak after taTME were analyzed based on the data registered in the Chinese taTME Registry Collaborative (CTRC). <strong>Methods:</strong> A case-control study was carried out. Between November 15, 2017 and December 31, 2020, clinical data of 1668 patients undergoing taTME procedure registered in the CTRC database from 43 domestic centers were collected retrospectively. After excluding 98 cases without anastomosis and 109 cases without complete postoperative complication data, 1461 patients were finally enrolled for analysis. There were 1036 males (70.9%) and 425 females (29.1%) with mean age of (58.2±15.6) years and mean body mass index of (23.6±3.8) kg/m(2). Anastomotic leak was diagnosed and classified according to the International Study Group of Rectal Cancer (ISREC) criteria. The risk factors associated with postoperative anastomotic leak cases were analyzed. The impact of the cumulative number of taTME surgeries in a single center on the incidence of anastomotic leak was evaluated. As for those centers with the number of taTME surgery ≥ 40 cases, incidence of anastomic leak between 20 cases of taTME surgery in the early and later phases was compared. <strong>Results:</strong> Of 1461 patients undergoing taTME, 103(7.0%) developed anastomotic leak, including 71 (68.9%) males and 32 (31.1%) females with mean age of (59.0±13.9) years and mean body mass index of (24.5±5.7) kg/m(2). The mean distance between anastomosis site and anal verge was (2.6±1.4) cm. Thirty-nine cases (37.9%) were classified as ISREC grade A, 30 cases (29.1%) as grade B and 34 cases (33.0%) as grade C. Anastomotic leak occurred in 89 cases (7.0%,89/1263) in the laparoscopic taTME group and 14 cases (7.1%, 14/198) in the pure taTME group. Multivariate analysis showed that hand-sewn anastomosis (<em>P</em>=0.004) and the absence of defunctioning stoma (<em>P</em>=0.013) were independently associated with anastomotic leak after taTME. In the 16 centers (37.2%) which performed ≥ 30 taTME surgeries with cumulative number of 1317 taTME surgeries, 86 cases developed anastomotic leak (6.5%, 86/1317). And in the 27 centers which performed less than 30 taTME surgeries with cumulative number of 144 taTME surgeries, 17 cases developed anastomotic leak (11.8%, 17/144). There was significant difference between two kinds of center (χ(2)=5.513, <em>P</em>=0.019). Thirteen centers performed ≥ 40 taTME surgeries. In the early phase (the first 20 cases in each center), 29 cases (11.2%, 29/260) developed anastomotic leak, and in the later phase, 12 cases (4.6%, 12/260) developed anastomotic leak. The difference between the early phase and the later phase was statistically significant (χ(2)=7.652, <em>P</em>=0.006). <strong>Conclusion:</strong> The incidence of anastomotic leak after taTME may be reduced by using stapler and defunctioning stoma, or by accumulating experience. <br></p>

目的： 经肛全直肠系膜切除术（taTME）自开展以来经历了最初的欣喜狂热到后来的冷静反思阶段，充满争议。而挪威卫生部叫停taTME，其原因之一就是较高的术后吻合口漏发生率。本研究通过统计中国taTME病例登记协作研究（CTRC）数据库中的病例资料，了解我国taTME术后吻合口漏的发生情况，并进行危险因素分析。 方法： 采用病例对照研究方法，回顾性收集2017年11月15日至2020年12月31日期间，CTRC数据库中来自全国43家中心的1 668例taTME手术患者的临床病例资料，排除未行消化道重建的98例患者以及术后并发症资料不完整的109例患者，1 461例患者纳入分析；男性1 036例（70.9%），女性425例（29.1%）；年龄（58.2±15.6）岁；体质指数（23.6±3.8）kg/m(2)。根据国际直肠癌研究组（ISREC）严重程度分级标准定义吻合口漏及其严重程度，统计taTME术后发生吻合口漏的情况；分析术后吻合口漏的危险因素；评估单中心累计taTME手术例数的多少对发生吻合口漏的影响，了解taTME手术登记数≥40例的高流量中心在taTME开展初期的20例与近期开展的20例发生吻合口漏的情况并进行比较。 结果： 本组1 461例接受taTME手术的患者发生吻合口漏103例（7.0%）。其中男性71例（68.9%），女性32例（31.1%）；年龄（59.0±13.9）岁；体质指数（24.5±5.7）kg/m(2)；吻合口距肛缘（2.6±1.4）cm；ISREC A级39例（37.9%），B级30例（29.1%），C级34例（33.0%）。腹腔镜辅助taTME（Lap-taTME）组发生吻合口漏89例（7.0%，89/1 263），单纯经肛taTME（pure-taTME）组14例（7.1%，14/198）。taTME术后吻合口漏发生的多因素分析结果显示，未使用吻合器吻合（P=0.004）和未行预防性造口（P=0.013）为taTME术后发生吻合口漏的独立危险因素。taTME手术登记数≥30例的中心有16个（37.2%），taTME手术累计例数1 317例，发生吻合口漏86例（6.5%）；而<30例的中心有27个，累计手术144例，发生吻合口漏17例（11.8%），两者比较，差异有统计学意义（χ(2)=5.513，P=0.019）。taTME手术登记数≥40例的中心有13个，前期的260例患者发生