Department of General, Visceral and Transplant Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Study Centre of the German Surgical Society (SDGC), Heidelberg, Germany.
World J Emerg Surg. 2023 Oct 17;18(1):51. doi: 10.1186/s13017-023-00517-4.
High-level evidence regarding the technique of abdominal wall closure for patients undergoing emergency midline laparotomy is sparse. Therefore, we conducted a randomized controlled trial (RCT) to evaluate the efficacy and safety of two commonly applied abdominal wall closure strategies after primary emergency midline laparotomy.
METHODS/DESIGN: CONTINT was a multi-center pragmatic open-label exploratory randomized controlled parallel trial. Two different abdominal wall closure strategies in patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity were compared: the continuous, all-layer suture and the interrupted suture technique. The primary composite endpoint was burst abdomen within 30 days after surgery or incisional hernia within 12 months. As reliable data on this composite primary endpoint were not available for patients undergoing emergency surgery, it was planned to initially recruit 80 patients and conduct an interim analysis after these had completed the 12 months follow-up.
From August 31, 2009, to June 28, 2012, 124 patients were randomized of whom 119 underwent surgery and were analyzed according to the intention-to-treat (ITT) principal. The primary composite endpoint did not differ between the continuous suture (C: 27.1%) and the interrupted suture group (I: 30.0%). None of the individual components of the primary endpoint (reoperation due to burst abdomen after 30 days (C: 13.5%, I: 15.1%) and reoperation due to incisional hernia (C: 3.0%, I:11.1%)) differed between groups. Time needed for fascial closure was longer in the interrupted suture group (C: 12.8 ± 4.5 min, I: 17.4 ± 6.1 min). BMI was associated with burst abdomen during the first 30 days with an OR of 1.17 (95% CI 1.04-1.32).
This RCT showed no difference between continuous suture with slowly absorbable suture versus interrupted rapidly absorbable sutures after primary emergency midline laparotomy in rates of postoperative burst abdomen and incisional hernia after one year. However, the trial was stopped after the interim analysis due to futility as there was no chance to show superiority of one suture technique.
关于行急诊正中切开术患者腹壁关闭技术的高级别证据稀缺。因此，我们进行了一项随机对照试验（RCT），以评估两种常用于原发性急诊正中切开术后的腹壁关闭策略的疗效和安全性。
方法/设计：CONTINT 是一项多中心实用开放性探索性随机对照平行试验。对接受原发性正中切开术的患者进行比较，这些患者因疑似腹腔内感染焦点而行紧急外科干预：连续全层缝合与间断缝合技术。主要复合终点是术后 30 天内发生腹部膨出或术后 12 个月内发生切口疝。由于没有可靠数据可用于接受急诊手术的患者，因此计划最初招募 80 例患者，并在完成 12 个月随访后进行中期分析。
2009 年 8 月 31 日至 2012 年 6 月 28 日，共随机分配 124 例患者，其中 119 例患者接受了手术并根据意向治疗（ITT）原则进行了分析。连续缝合组（C：27.1%）和间断缝合组（I：30.0%）的主要复合终点没有差异。主要终点的各个组成部分均无差异（术后 30 天因腹部膨出而再次手术（C：13.5%，I：15.1%）和因切口疝而再次手术（C：3.0%，I：11.1%））。间断缝合组的筋膜关闭时间更长（C：12.8±4.5min，I：17.4±6.1min）。BMI 与术后 30 天内发生腹部膨出相关，OR 为 1.17（95%CI 1.04-1.32）。
这项 RCT 表明，在原发性急诊正中切开术后，连续缝合与间断快速可吸收缝线在术后 1 年的术后腹部膨出和切口疝发生率方面无差异。然而，由于无效，试验在中期分析后停止，因为没有机会显示一种缝线技术的优越性。
