Antolovic Dalibor, Reissfelder Christoph, Rakow Anastasia, Contin Pietro, Rahbari Nuh N, Büchler Markus W, Weitz Jürgen, Koch Moritz
Department of Surgery, University of Heidelberg, Germany.
BMC Surg. 2011 Mar 3;11:7. doi: 10.1186/1471-2482-11-7.
Due to the increase of cardiovascular diseases acetylsalicylic acid (ASA) has become one of the most frequently prescribed drugs these days. Despite the rising number of patients with ASA medication presenting for elective general and abdominal surgery and the potentially increased risk of hemorrhage in these patients, there are no clear, evidence-based guidelines for the perioperative use of antiplatelet agents. The present randomised controlled trial was designed to evaluate the safety and optimize the use of ASA in the perioperative management of patients undergoing general and abdominal surgery.
METHODS/DESIGN: This is a two-arm, monocenter randomised controlled trial. Patients scheduled for elective surgical treatment (i.e. inguinal hernia repair, cholecystectomy and colorectal resections) with ASA as a permanent medication are randomised equally to perioperative continuation or discontinuation of ASA. Patients who are randomised in the discontinuation group stop the administration of ASA five days prior to surgical treatment and start intake of ASA on postoperative day 5. Fifty-two patients will be enrolled in this trial. The primary outcome is the incidence of postoperative bleeding and cardiovascular events at 30 days after surgery. In addition a set of general as well as surgical variables are analysed.
This is a randomised controlled two-group parallel trial designed to assess the safety and optimize the use of ASA in the perioperative management of patients undergoing general and abdominal surgery. The results of this pilot study build the basis for a confirmative randomised controlled trial that may help to clarify the use and potential risk/benefits of perioperative ASA medication in patients undergoing elective surgery.
The trial is registered with Current Controlled Trials ISRCTN45810007.
由于心血管疾病的增加，乙酰水杨酸（ASA）如今已成为最常用的处方药之一。尽管服用ASA进行择期普通外科和腹部手术的患者数量不断增加，且这些患者出血风险可能增加，但目前尚无关于围手术期使用抗血小板药物的明确、循证指南。本随机对照试验旨在评估ASA在接受普通外科和腹部手术患者围手术期管理中的安全性，并优化其使用。
方法/设计：这是一项双臂、单中心随机对照试验。计划接受择期手术治疗（即腹股沟疝修补术、胆囊切除术和结直肠切除术）且长期服用ASA的患者被随机分为围手术期继续或停用ASA两组。随机分入停药组的患者在手术治疗前5天停止服用ASA，并在术后第5天重新开始服用。本试验将招募52名患者。主要结局是术后30天出血和心血管事件的发生率。此外，还将分析一系列一般和手术变量。
这是一项随机对照两组平行试验，旨在评估ASA在接受普通外科和腹部手术患者围手术期管理中的安全性，并优化其使用。这项初步研究的结果为一项确定性随机对照试验奠定了基础，该试验可能有助于阐明围手术期ASA用药在接受择期手术患者中的使用情况及潜在风险/益处。
该试验已在Current Controlled Trials注册，注册号为ISRCTN45810007。
