本研究的目的是评估结肠或直肠癌手术后有和没有吻合口漏的患者的肿瘤预后。吻合口漏在结直肠癌手术后肿瘤结局中的作用仍是争论的话题，对随访和进一步治疗的影响尚不清楚。

对纳入国际多中心、非劣、开放标签、随机对照试验COLOR和COLOR II的患者进行分析，比较腹腔镜手术治疗可治愈结肠癌(COLOR)和直肠癌(COLOR II)与开放手术。经腹会阴切除术的患者被排除在外。进行单因素和多因素分析，以调查漏液对总生存期、无病生存期、局部和远处复发的影响，并对可能的混杂因素进行了调整。COLOR和COLOR II试验的主要终点分别为无病生存期和3年随访时的局部复发，次要终点包括吻合口漏率。

对于结肠癌，吻合口漏与局部复发率增加或无病生存期降低无关。直肠癌局部复发增加(13.3% vs 4.6%;危险比2.96;95%置信区间1.38-6.34;P = 0.005)，无病生存率降低(53.6% vs 70.9%;危险比1.67;95%置信区间1.16-2.41;P = 0.006)在5年随访中发现吻合口漏的患者。直肠癌术后吻合口漏的发生对短期发病率、死亡率和长期肿瘤预后有负面影响。对于结肠癌，未观察到显著影响;但由于功率较低，目前还没有得出吻合口漏对结肠手术后结局影响的结论。在整个随访过程中，临床必须意识到吻合口漏局部复发的风险增加。

Abstract

Objective: The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery.

Summary of background data: The role of anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear.

Methods: Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate.

Results: For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38-6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16-2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage.

Conclusion: Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory.Trial Registration: Registered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.

原文链接

pubmed.ncbi.nlm.nih.gov/32224742/

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