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Continuous versus interrupted abdominal wall closure after emergency midline laparotomy: CONTINT: a randomized controlled trial [NCT00544583]
World Journal of Emergency Surgery ( IF 8 ) Pub Date : 2023-10-17 , DOI: 10.1186/s13017-023-00517-4
Georgios Polychronidis 1, 2 , Nuh N Rahbari 3 , Thomas Bruckner 4 , Anja Sander 4 , Florian Sommer 5 , Selami Usta 6 , Janssen Hermann 7 , Max Benjamin Albers 8 , Mine Sargut 9 , Phillip Knebel 1 , Rosa Klotz 1, 2
Affiliation  

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. 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.

中文翻译:

紧急中线剖腹手术后连续腹壁闭合与间断腹壁闭合:CONTINT:一项随机对照试验 [NCT00544583]

关于接受紧急中线剖腹手术的患者腹壁闭合技术的高级证据很少。因此,我们进行了一项随机对照试验(RCT)来评估初次紧急中线剖腹手术后两种常用腹壁闭合策略的有效性和安全性。CONTINT 是一项多中心实用性开放标签探索性随机对照平行试验。比较了腹腔内疑似脓毒病灶而接受初次中线剖腹探查紧急外科手术的患者的两种不同腹壁闭合策略:连续全层缝合和间断缝合技术。主要复合终点是术后 30 天内腹部破裂或 12 个月内切口疝。由于接受紧急手术的患者无法获得这一复合主要终点的可靠数据,因此计划首先招募 80 名患者,并在这些患者完成 12 个月的随访后进行中期分析。从2009年8月31日到2012年6月28日,124名患者被随机分配,其中119名接受了手术,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(30 天后因腹部爆裂而再次手术(C:13.5%,I:15.1%)和因切口疝而再次手术(C:3.0%,I:11.1%))在组间没有差异。间断缝合组筋膜闭合所需时间较长(C:12.8±4.5分钟,I:17.4±6.1分钟)。BMI 与前 30 天内的腹部爆裂相关,OR 为 1.17 (95% CI 1.04–1.32)。该随机对照试验显示,在初次紧急中线剖腹手术后,使用缓慢可吸收缝线连续缝合与间断快速吸收缝线在一年后术后腹部爆裂和切口疝发生率方面没有差异。然而,由于没有机会显示一种缝合技术的优越性,试验在中期分析后因徒劳而停止。
更新日期:2023-10-17
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