Outcome Research, Healthcare Administration, IRCCS Istituto Romagnolo per lo studio dei tumori (IRST) " Dino Amadori", Meldola, Italy.
U.O. Chirurgia Generale, Hospital "Santa Maria delle Croci", AUSL, Ravenna, Romagna, Italy.
Int J Colorectal Dis. 2022 Jul;37(7):1727-1738. doi: 10.1007/s00384-022-04203-w. Epub 2022 Jul 2.
PURPOSE: Surgery is the main treatment for non-metastatic colorectal cancer. Despite huge improvements in perioperative care, colorectal surgery is still associated with a significant burden of postoperative complications and ultimately costs for healthcare organizations. Systematic clinical auditing activity has already proven to be effective in measuring and improving clinical outcomes, and for this reason, we decided to evaluate its impact in a large area of northern Italy. METHODS: The Emilia-Romagna Surgical Colorectal Audit (ESCA) is an observational, multicentric, retro-prospective study, carried out by 7 hospitals located in the Emilia-Romagna region. All consecutive patients undergoing surgery for colorectal cancer during a 54-month study period will be enrolled. Data regarding baseline conditions, preoperative diagnostic work-up, surgery and postoperative course will be collected in a dedicated case report form. Primary outcomes regard postoperative complications and mortality. Secondary outcomes include each center's adherence to the auditing (enrolment rate) and evaluation of the systematic feedback activity on key performance indicators for the entire perioperative process. CONCLUSION: This protocol describes the methodology of the Emilia-Romagna Surgical Colorectal Audit. The study will provide real-world clinical data essential for benchmarking and feedback activity, to positively impact outcomes and ultimately to improve the entire healthcare process of patients undergoing colorectal cancer surgery. CLINICAL TRIAL REGISTRATION: The study ESCA is registered on the clinicaltrials.gov platform (Identifier: NCT03982641).
目的:手术是非转移性结直肠癌的主要治疗方法。尽管围手术期护理有了巨大的进步,但结直肠手术仍然与术后并发症和医疗保健组织最终成本的巨大负担相关。系统的临床审核活动已被证明在衡量和改善临床结果方面是有效的,因此,我们决定在意大利北部的一个大区域评估其影响。
方法:艾米利亚-罗马涅外科结直肠审核(ESCA)是一项观察性、多中心、回顾性研究,由位于艾米利亚-罗马涅地区的 7 家医院进行。将招募在 54 个月研究期间接受结直肠癌手术的所有连续患者。将在专门的病例报告表中收集有关基线情况、术前诊断工作、手术和术后过程的数据。主要结果是术后并发症和死亡率。次要结果包括每个中心对审核的参与率(登记率)以及对整个围手术期关键绩效指标的系统反馈活动的评估。
结论:本方案描述了艾米利亚-罗马涅外科结直肠审核的方法学。该研究将提供基准测试和反馈活动所需的真实世界临床数据,以积极影响结果并最终改善接受结直肠癌手术的患者的整个医疗保健过程。
临床试验注册:该研究 ESCA 在 clinicaltrials.gov 平台上注册(标识符:NCT03982641)。
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