Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany.
Trials. 2012 May 30;13:72. doi: 10.1186/1745-6215-13-72.
The optimal strategy for abdominal wall closure has been an issue of ongoing debate. Available studies do not specifically enroll patients who undergo emergency laparotomy and thus do not consider the distinct biological characteristics of these patients. The present randomized controlled trial evaluates the efficacy and safety of two commonly applied abdominal wall closure strategies in patients undergoing primary emergency midline laparotomy.
METHODS/DESIGN: The CONTINT trial is a multicenter, open label, randomized controlled trial with a two-group parallel design. Patients undergoing a primary emergency midline laparotomy are enrolled in the trial. The two most commonly applied strategies of abdominal wall closure after midline laparotomy are compared: the continuous, all-layer suture technique using slowly absorbable monofilament material (two Monoplus loops) and the interrupted suture technique using rapidly absorbable braided material (Vicryl sutures). The primary endpoint within the CONTINT trial is an incisional hernia within 12 months or a burst abdomen within 30 days after surgery. As reliable data on this primary endpoint is not available for patients undergoing emergency surgery, an adaptive interim analysis will be conducted after the inclusion of 80 patients, allowing early termination of the trial if necessary or modification of design characteristics such as recalculation of sample size.
This is a randomized controlled multicenter trial with a two-group parallel design to assess the efficacy and safety of two commonly applied abdominal wall closure strategies in patients undergoing primary emergency midline laparotomy.
NCT00544583.
腹壁关闭的最佳策略一直是一个持续争论的问题。现有的研究并没有专门招募接受紧急剖腹手术的患者，因此没有考虑到这些患者的独特生物学特征。本随机对照试验评估了两种常用的腹壁关闭策略在接受原发性紧急中线剖腹手术患者中的疗效和安全性。
方法/设计：CONTINT 试验是一项多中心、开放标签、随机对照试验，采用两臂平行设计。招募接受原发性紧急中线剖腹手术的患者。比较两种最常用的中线剖腹术后腹壁关闭策略：使用可缓慢吸收的单丝材料（双 Monoplus 环）进行连续全层缝合技术和使用可快速吸收的编织材料（Vicryl 缝线）进行间断缝合技术。CONTINT 试验的主要终点是术后 12 个月内切口疝或术后 30 天内腹部破裂。由于对于接受紧急手术的患者，关于这个主要终点的可靠数据尚不可用，因此在纳入 80 例患者后将进行适应性中期分析，如果需要，可以提前终止试验或修改设计特征，例如重新计算样本量。
这是一项随机对照多中心试验，采用两臂平行设计，评估两种常用的腹壁关闭策略在接受原发性紧急中线剖腹手术患者中的疗效和安全性。
NCT00544583。
