Straatman Jennifer, Cuesta Miguel A, Schreurs W H Hermien, Dwars Boudewijn J, Cense Huib A, Rijna Herman, Sonneveld D J A Eric, den Boer Frank C, de Lange-de Klerk Elly S M, van der Peet Donald L
Department of Gastrointestinal Surgery, VU Medical Center, De Boelelaan 1117, 1081, , HV, Amsterdam, The Netherlands.
Department of Surgery, Medisch Centrum Alkmaar, Wilhelminalaan 12, 1815, , JD, Alkmaar, The Netherlands.
Trials. 2015 Aug 28;16:382. doi: 10.1186/s13063-015-0903-y.
After major abdominal surgery (MAS), 20% of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined.
A multicenter, stepped wedge, prospective clinical trial including all adult patients planned to undergo elective MAS. The first period consists of standard postoperative monitoring, which entails on demand additional examinations. This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. If CRP levels exceed 140 mg/L on postoperative day 3,4 or 5, an enhanced CT-scan is performed. Primary outcome in this study is a combined primary outcome, entailing all morbidity and mortality due to postoperative complications. Complications are graded according to the Clavien-Dindo classification. Secondary outcomes are hospital length of stay, patients reported outcome measures (PROMs) and cost-effectiveness. Data will be collected during admission, three months and one year postoperatively. Approval by the medical ethics committee of the VU University Medical Center was obtained (ID 2015.114).
the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness.
www.ClinicalTrials.gov, NCT02102217. Registered 5 February 2015.
腹部大手术后，20%的患者会出现严重并发症，需要进行侵入性治疗，且与发病率和死亡率的增加相关。旨在早期识别有发生严重并发症风险患者的腹部大手术后质量控制算法可降低相关的发病率和死亡率。文献研究表明，C反应蛋白（CRP）作为术后并发症的早期标志物有良好前景，但临床意义尚未确定。
一项多中心、阶梯式楔形、前瞻性临床试验，纳入所有计划接受择期腹部大手术的成年患者。第一阶段包括标准的术后监测，即按需进行额外检查。随后是根据PRECious方案进行术后控制的阶段，这意味着对CRP水平进行标准化测量。如果术后第3、4或5天CRP水平超过140mg/L，则进行增强CT扫描。本研究的主要结局是综合主要结局，包括术后并发症导致的所有发病率和死亡率。并发症根据Clavien-Dindo分类进行分级。次要结局包括住院时间、患者报告结局指标（PROMs）和成本效益。数据将在入院时、术后三个月和一年收集。获得了阿姆斯特丹自由大学医学中心医学伦理委员会的批准（ID 2015.114）。
PRECious试验是一项阶梯式楔形、多中心、开放标签、前瞻性临床试验，旨在确定标准化术后质量控制算法对术后发病率和死亡率以及成本效益的影响。
