Rahbari Nuh N, Diener Markus K, Fischer Lars, Wente Moritz N, Kienle Peter, Büchler Markus W, Seiler Christoph M
Department of General, Visceral and Trauma Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany.
Trials. 2008 Jan 24;9:3. doi: 10.1186/1745-6215-9-3.
Although considered the reference standard for generating valid scientific evidence of a treatment's benefits and harms, the number of Randomised Controlled Trials (RCT) comparing surgical techniques remains low. Much effort has been made in order to overcome methodological issues and improve quality of RCTs in surgery. To the present there has been, however, only little emphasis on development and maintenance of institutions for implementation of adequately designed and conducted surgical RCTs.
METHODS/DESIGN: Description of the developments in surgical RCT infrastructure in Germany between 2001 and 2006. Cross sectional evaluation of completed and ongoing surgical RCTs within the German Surgical Society and the Clinical Study Centre, Department of Surgery, University of Heidelberg.
Foundation of a national Clinical Trial Centre (CTC) for the organisation of multi-centre RCTs in the surgical setting (Study Center of the German Surgical Society, SDGC). Establishment of a network of CTCs with affiliated Clinical Sites (CSs) to enhance patient recruitment and shorten the duration of RCTs. Since its foundation four surgical RCTs with a total sample size of 1650 patients (1006 of these randomised) have been supervised by the SDGC with 35 CSs involved in patient recruitment. Five further CTCs were set up in 2006. Together with their affiliated CSs a network has been organised providing improved conditions for the conduction of surgical RCTs.
Improvement of infrastructure substantially facilitates integration of RCTs into routine surgical practice. A network of collaborating CTCs and CSs can provide an adequate infrastructure for the conduction of multi-centre RCTs.
尽管随机对照试验（RCT）被视为生成关于治疗益处和危害的有效科学证据的参考标准，但比较手术技术的随机对照试验数量仍然很少。为克服方法学问题并提高手术领域随机对照试验的质量，人们付出了诸多努力。然而，目前对于建立和维持实施设计充分且执行良好的手术随机对照试验的机构却很少给予关注。
方法/设计：描述2001年至2006年间德国手术随机对照试验基础设施的发展情况。对德国外科学会和海德堡大学外科系临床研究中心内已完成和正在进行的手术随机对照试验进行横断面评估。
建立了一个国家临床试验中心（CTC），用于组织外科手术环境下的多中心随机对照试验（德国外科学会研究中心，SDGC）。建立了由附属临床站点（CS）组成的CTC网络，以增加患者招募并缩短随机对照试验的持续时间。自成立以来，SDGC已监督了四项手术随机对照试验，总样本量为1650名患者（其中1006名被随机分组），有35个临床站点参与患者招募。2006年又设立了另外五个临床试验中心。连同其附属的临床站点，已组织了一个网络，为进行手术随机对照试验提供了更好条件。
基础设施的改善极大地促进了随机对照试验融入常规外科实践。协作的临床试验中心和临床站点网络可为进行多中心随机对照试验提供适当的基础设施。
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