引用文本：陈燕芳, 曾茜林, 宋武, 等. 直肠癌根治术后不同吻合口保护策略对围手术期结局的影响[J/CD]. 消化肿瘤杂志（电子版）, 2026, 18(3): 432-442.

作者：陈燕芳1，曾茜林1，宋武2，方伟超1，郝腾飞1，周学付1

单位：1. 中山大学附属第七医院 消化医学中心，广东 深圳 518107；2. 中山大学附属第一医院 胃肠外科，广东 广州 510080

Authors：Chen Yanfang¹, Zeng Qianlin¹, Song Wu2, Fang Weichao¹, Hao Tengfei¹, Zhou Xuefu¹

Unit：1. Digestive Diseases Center, the Seventh Affiliated Hospital of Sun Yat-sen University, Shenzhen 518107, Guangdong, China；2. Department of Gastrointestinal Surgery, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, Guangdong, China

摘要：

目的 比较经肛门引流管、预防性造口与单纯吻合3种策略对直肠癌根治术后吻合口漏及并发症的影响。方法 采用双中心回顾性队列研究，纳入中山大学附属第一医院（2017年8月29日至2025年10月13日）2212例及中山大学附属第七医院（2018年6月7日至2026年4月23日）255例，共2467例行直肠癌根治性切除并完成一期吻合的首次手术患者（单纯吻合组1209例、预防性造口组625例、经肛门引流管组633例）。主要结局为吻合口漏；次要结局为总并发症与严重并发症。三组两两比较均采用倾向评分匹配（纳入8个协变量，采用1∶1最近邻无放回匹配，卡尺宽度为倾向评分标准差的0.2倍），匹配后采用McNemar确切概率法及配对OR比较组间结局，并以逆概率加权等进行敏感性分析。结果 倾向评分匹配分别形成370对（单纯吻合组与预防性造口组）、417对（单纯吻合组与经肛门引流管组）和305对（预防性造口组与经肛门引流管组）。吻合口漏方面，经肛门引流管组（2.2%比6.0%，OR=0.37，95%CI 0.18~0.78，P=0.009）与预防性造口组（1.9%比5.1%，OR=0.38，95%CI 0.17~0.89，P=0.029）的发生率均低于单纯吻合组，经肛门引流管组与预防性造口组的发生率差异无统计学意义（2.3%比1.0%，OR=2.60，95%CI 0.60~11.18，P=0.289）。与单纯吻合组相比，经肛门引流管组的总并发症（7.9%比13.9%，OR=0.54，95%CI 0.35~0.85，P=0.008）与严重并发症（3.1%比6.7%，OR=0.45，95%CI 0.23~0.89，P=0.024）发生率较低，预防性造口组的总并发症（7.8%比16.5%，OR=0.40，95%CI 0.24~0.66，P<0.001）与严重并发症（3.2%比7.0%，OR=0.38，95%CI 0.17~0.83，P=0.016）发生率亦较低；经肛门引流管组与预防性造口组的总并发症、严重并发症发生率差异均无统计学意义（均P=1.000）。逆概率加权敏感性分析结果方向与倾向评分匹配分析总体相近（与单纯吻合组相比，经肛门引流管组吻合口漏发生率的OR=0.59，95%CI 0.35~0.98，P=0.041；预防性造口组吻合口漏发生率的OR=0.39，95%CI 0.20~0.77，P=0.007）。结论 经肛门引流管与预防性造口相较于单纯吻合，均可降低吻合口漏、总并发症与严重并发症的发生风险；而经肛门引流管与预防性造口的各结局则相近。对不愿或不宜行造口的患者，经肛门引流管或可作为值得进一步研究的候选策略。

关键词：直肠肿瘤；吻合口漏；经肛门引流管；预防性造口；倾向评分；双中心

Abstract：

Objective To compare the effects of three strategies—transanal drainage tube, prophylactic stoma, and anastomosis alone—on anastomotic leakage and complications after radical resection of rectal cancer. Method This was a two-center retrospective cohort study. A total of 2467 patients who underwent radical resection of rectal cancer with primary anastomosis for the first time were included, comprising 2212 cases from the First Affiliated Hospital of Sun Yat-sen University (from August 29, 2017 to October 13, 2025) and 255 cases from the Seventh Affiliated Hospital of Sun Yat-sen University (from June 7, 2018 to April 23, 2026); 1209, 625, and 633 patients constituted the anastomosis alone group, the prophylactic stoma group, and the transanal drainage tube group, respectively. The primary outcome was anastomotic leakage; the secondary outcomes were overall complications and severe complications. Pairwise comparisons among the three groups were performed using propensity score matching (eight covariates; 1∶1 nearest-neighbor matching without replacement, with a caliper width of 0.2 times the standard deviation of the propensity score). After matching, outcomes were compared using the McNemar exact test and paired odds ratios (OR), and sensitivity analyses including inverse probability of treatment weighting (IPTW) were conducted. Result Propensity score matching yielded 370 pairs (anastomosis alone group vs. prophylactic stoma group), 417 pairs (anastomosis alone group vs. transanal drainage tube group), and 305 pairs (prophylactic stoma group vs. transanal drainage tube group). For anastomotic leakage, the incidence was lower in both the transanal drainage tube group (2.2% vs. 6.0%, OR=0.37, 95%CI 0.18-0.78, P=0.009) and the prophylactic stoma group (1.9% vs. 5.1%, OR=0.38, 95%CI 0.17-0.89, P=0.029) than in the anastomosis alone group, with no statistically significant difference between the transanal drainage tube and prophylactic stoma groups (2.3% vs. 1.0%, OR=2.60, 95%CI 0.60-11.18, P=0.289). Compared with the anastomosis alone group, the transanal drainage tube group had lower incidences of overall complications (7.9% vs. 13.9%, OR=0.54, 95%CI 0.35-0.85, P=0.008) and severe complications (3.1% vs. 6.7%, OR=0.45, 95%CI 0.23-0.89, P=0.024), as did the prophylactic stoma group (overall complications: 7.8% vs. 16.5%, OR=0.40, 95%CI 0.24-0.66, P<0.001; severe complications: 3.2% vs. 7.0%, OR=0.38, 95%CI 0.17-0.83, P=0.016). No statistically significant difference was found between the transanal drainage tube and prophylactic stoma groups for overall or severe complications (both P=1.000). The IPTW sensitivity analyses were generally consistent with the propensity score matching analysis (for anastomotic leakage, compared with the anastomosis alone group: transanal drainage tube, OR=0.59, 95%CI 0.35-0.98, P=0.041; prophylactic stoma, OR=0.39, 95%CI 0.20-0.77, P=0.007). Conclusion Compared with anastomosis alone, both the transanal drainage tube and prophylactic stoma were associated with lower risks of anastomotic leakage, overall complications, and severe complications, while the outcomes between transanal drainage tube and prophylactic stoma were similar. For patients who are unwilling or unsuitable for a stoma, a transanal drainage tube may be a candidate strategy warranting further investigation.

Key words：Rectal neoplasms; Anastomotic leakage; Transanal drainage tube; Prophylactic stoma; Propensity score; Two-center study

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