紧急中线剖腹术后持续与间断腹壁闭合:连续:一项随机对照试验[NCT00544583]。

IF 6 1区 医学 Q1 EMERGENCY MEDICINE
Georgios Polychronidis, Nuh N Rahbari, Thomas Bruckner, Anja Sander, Florian Sommer, Selami Usta, Janssen Hermann, Max Benjamin Albers, Mine Sargut, Phillip Knebel, Rosa Klotz
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引用次数: 0

摘要

背景:关于接受紧急中线剖腹手术的患者腹壁闭合技术的高水平证据很少。因此,我们进行了一项随机对照试验(RCT),以评估两种常用的腹壁闭合策略在初次紧急中线剖腹术后的疗效和安全性。方法/设计:CONTINT是一项多中心实用开放标签探索性随机对照平行试验。比较了两种不同的腹壁闭合策略:连续全层缝合和间断缝合技术,这两种策略适用于在疑似腹腔感染性病灶的情况下接受初级中线剖腹手术进行紧急手术干预的患者。主要复合终点是术后30天内腹部爆裂或12个月内切口疝。由于接受紧急手术的患者无法获得关于该复合主要终点的可靠数据,计划最初招募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。结果:从2009年8月31日到2012年6月28日,124名患者被随机分组,其中119人接受了手术,并根据意向治疗(ITT)原则进行分析。主要复合终点在连续缝合组(C:27.1%)和间断缝合组(I:30.0%)之间没有差异。主要终点的各个组成部分(30天后腹部爆裂再次手术(C:13.5%,I:15.1%)和切口疝再次手术(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天腹部爆裂相关,OR为1.17(95%CI 1.04-1.32)。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无效而停止。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Continuous versus interrupted abdominal wall closure after emergency midline laparotomy: CONTINT: a randomized controlled trial [NCT00544583].

Continuous versus interrupted abdominal wall closure after emergency midline laparotomy: CONTINT: a randomized controlled trial [NCT00544583].

Background: 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.

Results: 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).

Conclusion: 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.

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来源期刊
World Journal of Emergency Surgery
World Journal of Emergency Surgery EMERGENCY MEDICINE-SURGERY
CiteScore
14.50
自引率
5.00%
发文量
60
审稿时长
10 weeks
期刊介绍: The World Journal of Emergency Surgery is an open access, peer-reviewed journal covering all facets of clinical and basic research in traumatic and non-traumatic emergency surgery and related fields. Topics include emergency surgery, acute care surgery, trauma surgery, intensive care, trauma management, and resuscitation, among others.
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