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在发展中国家开展全国性前瞻性结直肠癌登记研究:如何实施、潜在局限性及初步研究结果

Starting a national, prospective colorectal cancer registry in a developing country: how to do it, potential limitations and results of a pilot study.

机构信息

Argentinian Colorectal Cancer Consortium, Buenos Aires, Argentina.

出版信息

Colorectal Dis. 2023 Aug;25(8):1598-1612. doi: 10.1111/codi.16634. Epub 2023 Jun 19.

DOI:10.1111/codi.16634
PMID:37337382
Abstract

AIM

Prospective registries of patients operated on for malignancies at a national scale are not common in developing countries. The aim of this work is to report the process of creation of a prospective national colorectal cancer registry in a middle-income country in Latin America and the main results of a pilot study involving eight centres.

METHOD

The project involved the creation of a national database including all patients operated on for colorectal cancer in Argentina and a 30-year plan to make improvements based on the information provided by the registry. The first phase comprised the prospective registration of all patients treated in eight tertiary referral centres during a 6-month period.

RESULTS

Three hundred and seventeen patients were prospectively recruited during the study period, and 244 (77%) were operated on for colon cancer. The completion rate for all variables was >95%. The median age for the group was 66.88 years. Right-sided colon tumours were the most frequent. Colorectal specialists performed 257 (81.07%) of the procedures, and in 273 (87.22%) patients a laparoscopic approach was used with an overall conversion rate of 12.45%. Major complication and anastomotic leakage rates for the group were 18.55% and 8.81%, respectively. The mortality rate was 1.94%. Multivariate analysis showed that young patients and operations performed by general surgeons were the most common factors independently related to worse postoperative outcomes. Note that this manuscript describes an early phase of the project that included only eight tertiary referral centres.

CONCLUSION

Despite its limitations, this study describes the effort made to generate reliable data on which to base future decisions to improve patient care. Furthermore, it might set an example for other developing countries to start their own registries.

摘要

目的

在发展中国家,针对恶性肿瘤患者进行全国范围内前瞻性登记的情况并不常见。本研究旨在报告在拉丁美洲一个中等收入国家创建全国结直肠癌前瞻性登记的过程,并报告涉及 8 个中心的初步研究结果。

方法

该项目涉及创建一个包含阿根廷所有结直肠癌患者的全国数据库,并制定了一个 30 年计划,根据该登记处提供的信息进行改进。第一阶段包括前瞻性登记在 8 个三级转诊中心治疗的所有患者,为期 6 个月。

结果

在研究期间,前瞻性纳入了 317 名患者,其中 244 名(77%)接受结肠癌手术治疗。所有变量的完成率>95%。该组的中位年龄为 66.88 岁。右侧结肠癌最为常见。257 例(81.07%)手术由结直肠专家完成,273 例(87.22%)患者采用腹腔镜方法,总体转化率为 12.45%。该组的主要并发症和吻合口漏发生率分别为 18.55%和 8.81%。死亡率为 1.94%。多变量分析显示,年轻患者和普通外科医生进行的手术是与术后不良结局最相关的常见因素。需要注意的是,本研究仅描述了该项目的早期阶段,仅包括 8 个三级转诊中心。

结论

尽管存在局限性,但本研究描述了为生成可靠数据所做的努力,这些数据可作为未来改善患者治疗的决策依据。此外,它可能为其他发展中国家提供了启动自己的登记处的范例。

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