Department of Surgery, University of Heidelberg, Heidelberg, Germany.
Surgery. 2011 Jan;149(1):48-55. doi: 10.1016/j.surg.2010.02.008. Epub 2010 Apr 10.
The aim of this trial was to confirm previous results demonstrating the efficacy and safety of a fixed combination tissue sealant versus argon beam coagulation (ABC) treatment in liver resection.
This trial was designed as an international, multicenter, randomized, controlled surgical trial with 2 parallel groups. Patients were eligible for intra-operative randomization after elective resection of ≥ 1 liver segment and primary hemostasis. The primary end point was the time to hemostasis after starting the randomized intervention to obtain secondary hemostasis. Secondary end points were drainage duration, volume, and content. Adverse events were collected to evaluate the safety of treatments. The trial was registered internationally (Eudract number 2008-006407-23).
Among 119 patients (60 TachoSil and 59 ABC) randomized in 10 tertiary care centers in Europe, the mean time to hemostasis was less when TachoSil was used (3.6 minutes) compared with ABC (5.0 minutes; P = .0018). The estimated ratio of mean time to hemostasis for TachoSil/ABC was 0.61 (95% confidence interval, 0.47-0.80; P = .0003). Postoperative drainage volume, drainage fluid, and drainage duration did not differ between the 2 groups. Mortality (2 vs 4 patients) and adverse reactions (24 vs 28 patients) for TachoSil versus ABC did not differ.
This trial confirmed that TachoSil achieved significantly faster hemostasis after liver resection compared with ABC. Postoperative morbidity and mortality remained unchanged between both groups.
本试验旨在证实先前的研究结果，即与氩束凝固（ABC）治疗相比，固定组合组织密封剂在肝切除术中具有疗效和安全性。
本试验设计为国际、多中心、随机、对照手术试验，分为 2 个平行组。在选择性切除≥1个肝段和初步止血后，患者有资格进行术中随机分组。主要终点是从开始随机干预到获得二次止血的止血时间。次要终点是引流持续时间、引流量和引流液成分。收集不良事件以评估治疗的安全性。该试验在国际上注册（Eudract 编号 2008-006407-23）。
在欧洲 10 个三级护理中心的 119 名患者（60 名 TachoSil 和 59 名 ABC）中进行了随机分组，与 ABC 相比，使用 TachoSil 时止血时间更短（3.6 分钟）（P =.0018）。TachoSil/ABC 的平均止血时间估计比值为 0.61（95%置信区间，0.47-0.80；P =.0003）。两组间术后引流体积、引流液和引流持续时间无差异。TachoSil 与 ABC 的死亡率（2 例与 4 例）和不良反应（24 例与 28 例）无差异。
本试验证实，与 ABC 相比，TachoSil 在肝切除术后能更快地止血。两组间术后发病率和死亡率保持不变。
