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腹腔镜与开放手术治疗直肠癌的长期肿瘤学结果 - 一项基于人群的全国性非劣效性研究。

Long term oncological outcomes for laparoscopic versus open surgery for rectal cancer - A population-based nationwide noninferiority study.

机构信息

Department of Surgery, Örebro University Hospital, Örebro, Sweden.

Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

出版信息

Colorectal Dis. 2022 Nov;24(11):1308-1317. doi: 10.1111/codi.16204. Epub 2022 Jul 11.

Abstract

AIM

The aim of this work was to compare the 5-year overall survival in a national cohort of patients undergoing curative abdominal resection for rectal cancer by laparoscopic (LAP) or open (OPEN) surgery.

METHOD

All patients diagnosed with clinical Stage I-III rectal cancer and who underwent LAP or OPEN abdominal curative surgery in Sweden between 2010 and 2016 were retrieved from the Swedish Colorectal Cancer Registry. A noninferiority study design was employed with a statistical power of 90%, a one-side type I error of 2.5% and a noninferiority margin of 2%. The analyses were performed as intention-to-treat and the relationship between surgical technique and overall mortality within 5 years was analysed. Multilevel regression models with the patients matched by propensity scores adjusted for patient- and tumour-related variables were used.

RESULTS

A total of 8410 Stage I-III cancer patients were included. This group underwent 2094 LAP (24.9%) and 6316 OPEN (75.1%) procedures and were followed until 31 December 2020. Multivariable Cox regression demonstrated that 5-year overall survival was higher in the LAP group [hazard ratio (HR) 0.877; 95% CI 0.775-0.993]. [Correction added on 21 November 2022, after first online publication: In the preceding sentence, the CI value for LAP group has been corrected from "0.877" to "0.775" in this version.] The outcome was similar when multiple imputation and propensity score matching were employed. When cT4 patients were excluded there was no difference (HR 0.885; 95% CI 0.790-1.033). At 5-years' follow-up local recurrence was not different, at 2.9% for the LAP group and 3.6% for the OPEN group (p = 0.075), while metastatic disease was more frequent in the OPEN group (19.6% compared with 15.6% for LAP; p < 0.001).

CONCLUSION

This study demonstrated that the LAP technique was not inferior to OPEN surgery with regard to overall 5-year survival. These results support the use of laparoscopic surgery.

摘要

目的

本研究旨在比较腹腔镜(LAP)和开腹(OPEN)手术治疗直肠肿瘤的患者 5 年总生存率。

方法

从瑞典结直肠癌登记处检索了 2010 年至 2016 年间在瑞典接受 LAP 或 OPEN 腹部根治性手术治疗的临床 I-III 期直肠腺癌患者。采用非劣效性研究设计,统计效能为 90%,单侧Ⅰ类错误为 2.5%,非劣效性边界为 2%。分析采用意向治疗,分析 5 年内手术技术与总死亡率之间的关系。使用患者倾向性评分匹配的多水平回归模型,调整患者和肿瘤相关变量。

结果

共纳入 8410 例 I-III 期癌症患者,其中 2094 例接受 LAP(24.9%),6316 例接受 OPEN(75.1%)治疗,并随访至 2020 年 12 月 31 日。多变量 Cox 回归显示,LAP 组 5 年总生存率更高[风险比(HR)0.877;95%置信区间(CI)0.775-0.993]。[2022 年 11 月 21 日更正,在首次在线出版后,上一句中 LAP 组的 CI 值从“0.877”更正为“0.775”。]当采用多元缺失和倾向评分匹配时,结果相似。当排除 cT4 患者时,无差异(HR 0.885;95% CI 0.790-1.033)。5 年随访时局部复发率无差异,LAP 组为 2.9%,OPEN 组为 3.6%(p=0.075),而 OPEN 组远处转移更为常见(19.6%比 LAP 组 15.6%;p<0.001)。

结论

本研究表明,LAP 技术在 5 年总生存率方面不劣于 OPEN 手术。这些结果支持腹腔镜手术的应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8c9/9796648/a5b22bd93ef6/CODI-24-1308-g004.jpg

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