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Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer

机译:腹腔镜与开腹手术治疗结肠癌的随机试验的十年结果

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摘要

Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up. Between March 1997 and March 2003, patients with non-metastatic colon cancer were recruited by 29 hospitals in eight countries and randomised to either laparoscopic or open surgery. Main inclusion criterion for the COLOR trial was solitary adenocarcinoma of the left or right colon. The primary outcome was disease-free survival at 3 years, and secondary outcomes included overall survival and recurrence. The 10-year follow-up data of all Dutch patients were collected. Analysis was by intention-to-treat. The trial was registered at ClinicalTrials.gov (NCT00387842). In total, 1248 patients were randomised, of which 329 were Dutch. Fifty-eight Dutch patients were excluded and 15 were lost to follow-up, leaving 256 patients for 10-year analysis. Median follow-up was 112 months. Disease-free survival rates were 45.2 % in the laparoscopic group and 43.2 % in the open group (difference 2.0 %; 95 % confidence interval (CI) -10.3 to 14.3; p = 0.96). Overall survival rates were 48.4 and 46.7 %, respectively (difference 1.7 %; 95 % CI -10.6 to 14.0; p = 0.83). Stage-specific analysis revealed similar survival rates for both groups. Sixty-two patients were diagnosed with recurrent disease, accounting for 29.4 % in the laparoscopic group and 28.2 % in the open group (difference 1.2 %; 95 % CI -11.1 to 13.5; p = 0.73). Seven patients had port- or wound-site recurrences (laparoscopic n = 3 vs. open n = 4). Laparoscopic surgery for non-metastatic colon cancer is associated with similar rates of disease-free survival, overall survival and recurrences as open surgery at 10-year follow-up.
机译:与开放手术相比,腹腔镜结肠癌手术在3年和5年时可提高康复率,并具有相似的癌症结局。但是,很少有长期存活率的报道。在这里,我们介绍了在10年的随访中纳入结肠癌腹腔镜或开放切除术(COLOR)试验的荷兰患者的生存率和复发率。在1997年3月至2003年3月之间,非转移性结肠癌患者被八个国家的29家医院招募,并随机分为腹腔镜手术或开腹手术。 COLOR试验的主要纳入标准为左或右结肠孤立性腺癌。主要结局是3年无病生存,次要结局包括总体生存和复发。收集了所有荷兰患者的10年随访数据。分析是按意向性进行的。该试验已在ClinicalTrials.gov(NCT00387842)上注册。总共有1248名患者被随机分组​​,其中329名是荷兰人。排除了58位荷兰患者,其中15位失访,剩下256位患者需要进行10年分析。中位随访时间为112个月。腹腔镜组无病生存率为45.2%,开放组为43.2%(差异2.0%; 95%置信区间(CI)-10.3至14.3; p = 0.96)。总生存率分别为48.4%和46.7%(差异1.7%; 95%CI -10.6至14.0; p = 0.83)。特定阶段的分析显示两组的存活率相似。 62例被诊断患有复发性疾病,腹腔镜组占29.4%,开放组占28.2%(差异1.2%; 95%CI -11.1至13.5; p = 0.73)。 7例患者出现了部位或伤口部位复发(腹腔镜检查n = 3 vs.开放性n = 4)。腹腔镜手术治疗非转移性结肠癌的无病生存率,总体生存率和复发率与10年随访开放手术相似。

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