Seiler C M, Fröhlich B E, Veit J A, Gazyakan E, Wente M N, Wollermann C, Deckert A, Witte S, Victor N, Buchler M W, Knaebel H P
Study Center of the German Surgical Society (SDGC), University of Heidelberg, Germany.
Trials. 2006 Sep 1;7:27. doi: 10.1186/1745-6215-7-27.
Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT.
METHODS/DESIGN: CLIVIT (Clips versus Ligatures in Thyroid Surgery) is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min) when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers.
As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.
在德国，每年要进行超过90000例甲状腺手术。旨在缩短手术时长的策略对患者和医疗保健系统都很重要，尤其是在降低成本的背景下。然而，在给出一般性建议之前，新的快速安全止血技术必须在具有临床相关性的随机对照试验中进行测试。甲状腺手术中血管闭塞的当前标准是结扎。血管夹可能是一种安全的替代方法，但尚未在大型随机对照试验中进行研究。
方法/设计：CLIVIT（甲状腺手术中血管夹与结扎术对比）是一项由德国外科学会研究中心发起的、多中心、患者盲法、两组平行的相关性随机对照试验。计划因良性甲状腺疾病对至少三分之二的腺体进行择期切除的患者有资格参与。手术探查后，患者在术中被随机分为传统结扎组或血管夹组。主要目的是测试使用血管夹技术时手术时间是否有显著缩短（至少15分钟）。自2004年4月以来，在五个中心对总共420名所需患者中的121名进行了随机分组。
与所有试验一样，必须考虑不同形式的偏倚，在这种情况下，作为一项外科试验，手术专业知识的作用起着关键作用，将单独记录和分析。这是第一项具有足够效力以及关于设计和框架的其他详细信息的、比较甲状腺手术中不同血管闭塞技术的随机对照多中心相关性试验。如果结果显著，可能会推广并改变当前的手术实践。
