全球癌症手术的质量和结果:一项多中心、国际、前瞻性队列研究的方案(GlobalSurg 3)。
Quality and outcomes in global cancer surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 3).
出版信息
BMJ Open. 2019 May 24;9(5):e026646. doi: 10.1136/bmjopen-2018-026646.
INTRODUCTION
Empirical, observational data relating to the diagnosis, management and outcome of three common worldwide cancers requiring surgery is lacking. However, it has been demonstrated that patients in low/middle-income countries undergoing surgery for cancer are at increased risk of death and major complications postoperatively. This study aims to determine quality and outcomes in breast, gastric and colorectal cancer surgery across worldwide hospital settings.
METHODS AND ANALYSIS
This multicentre, international prospective cohort study will be undertaken by any hospital providing emergency or elective surgical services for breast, gastric or colorectal cancer. Centres will collect observational data on consecutive patients undergoing primary emergency or elective surgery for breast, gastric or colorectal cancer during a 6-month period. The primary outcome is the incidence of mortality and major complication rate at 30 days after cancer surgery. Infrastructure and care processes in the treatment of these cancers worldwide will also be characterised.
ETHICS AND DISSEMINATION
This project will not affect clinical practice and has been classified as clinical audit following research ethics review. The protocol will be disseminated through the international GlobalSurg network.
TRIAL REGISTRATION NUMBER
NCT03471494; Pre-results.
简介
缺乏与三种常见全球需要手术治疗的癌症的诊断、管理和结果相关的经验性、观察性数据。然而,已经表明,在中低收入国家接受癌症手术的患者术后死亡和主要并发症的风险增加。本研究旨在确定全球医院环境中乳腺癌、胃癌和结直肠癌手术的质量和结果。
方法和分析
这项多中心、国际前瞻性队列研究将由任何提供乳腺癌、胃癌或结直肠癌急诊或择期手术服务的医院进行。中心将在 6 个月的时间内连续收集接受乳腺癌、胃癌或结直肠癌原发性急诊或择期手术的患者的观察性数据。主要结局是癌症手术后 30 天的死亡率和主要并发症发生率。还将描述全球治疗这些癌症的基础设施和护理流程。
伦理和传播
该项目不会影响临床实践,并在经过研究伦理审查后被归类为临床审计。该方案将通过国际 GlobalSurg 网络进行传播。
试验注册编号
NCT03471494;预结果。
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