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机器人与腹腔镜右半结肠切除术的长期肿瘤学结果:一项前瞻性随机研究。

Long-term oncologic after robotic versus laparoscopic right colectomy: a prospective randomized study.

机构信息

Colorectal Cancer Center, School of Medicine, Kyungpook National University Medical Center, Kyungpook National University, Daegu, South Korea.

Kyungpook National University Bio-Medical Research Institute, Daegu, South Korea.

出版信息

Surg Endosc. 2019 Sep;33(9):2975-2981. doi: 10.1007/s00464-018-6563-8. Epub 2018 Nov 19.

DOI:10.1007/s00464-018-6563-8
PMID:30456502
Abstract

OBJECTIVE

The aim of this study was to compare the long-term outcomes of robot-assisted right colectomy (RAC) with those for conventional laparoscopy-assisted right surgery (LAC) for treating right-sided colon cancer.

BACKGROUND

The enthusiasm for the robotic techniques has gained increasing interest in colorectal malignancies. However, the role of robotic surgery in the oncologic safety has not yet been defined.

METHODS

From September 2009 to July 2011, 71 patients with right-sided colonic cancer were randomized in the study. Adjuvant therapy and postoperative follow-up were similar in both groups. The primary and secondary endpoints of the study were hospital stay and survival, respectively. Data were analyzed by intention-to-treat principle.

RESULTS

The RAC and LAC groups did not differ significantly in terms of baseline clinical characteristics. Compared with the LAC group, RAC was associated with longer operation times (195 min vs. 129 min, P < 0.001) and higher cost ($12,235 vs. $10,319, P = 0.013). The median follow-up was 49.23 months (interquartile range 40.63-56.20). The combined 5-year disease-free rate for all tumor stages was 77.4% (95% confidence interval [CI], 60.6-92.1%) in the RAC group and 83.6% (95% CI 72.1-0.97.0%) in the LAC group (P = 0.442). The combined 5-year overall survival rates for all stages were 91.1% (95% CI 78.8-100%) in the RAC group and 91.0% (95% CI 81.3-100%) in the LAC group (P = 0.678). Using multivariate analysis, RAC was not a predictor of recurrence.

CONCLUSIONS

RAC appears to similar long-term survival as compared with LAC. However, we did not observe any clinical benefits of RAC which could translate to a decrease in expenditures.

TRIAL REGISTRY

http://www.ClinicalTrials.gov , number NCT00470951.

摘要

目的

本研究旨在比较机器人辅助右结肠切除术(RAC)与传统腹腔镜辅助右结肠切除术(LAC)治疗右侧结肠癌的长期疗效。

背景

机器人技术的应用受到结直肠恶性肿瘤治疗的广泛关注。然而,机器人手术在肿瘤安全性方面的作用尚未明确。

方法

2009 年 9 月至 2011 年 7 月,71 例右半结肠癌患者参与本研究。两组患者术后均采用相同的辅助治疗及随访。研究的主要和次要终点分别为住院时间和生存时间。数据采用意向治疗原则进行分析。

结果

RAC 组和 LAC 组患者的基线临床特征无显著差异。与 LAC 组相比,RAC 组的手术时间更长(195 分钟 vs. 129 分钟,P<0.001),费用更高(12235 美元 vs. 10319 美元,P=0.013)。中位随访时间为 49.23 个月(四分位距 40.63-56.20)。所有肿瘤分期的 5 年无病生存率在 RAC 组为 77.4%(95%CI,60.6-92.1%),在 LAC 组为 83.6%(95%CI,72.1-0.97.0%)(P=0.442)。所有分期的 5 年总生存率在 RAC 组为 91.1%(95%CI,78.8-100%),在 LAC 组为 91.0%(95%CI,81.3-100%)(P=0.678)。多因素分析显示,RAC 不是复发的预测因素。

结论

与 LAC 相比,RAC 似乎具有相似的长期生存获益。然而,我们没有观察到 RAC 的任何临床获益可以转化为费用的降低。

试验注册

www.ClinicalTrials.gov,编号 NCT00470951。

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