Interrupted or Continuous Slowly Absorbable Sutures For Closure of Primary Elective Midline Abdominal Incisions A Multicenter Randomized Trial (INSECT: ISRCTN24023S41)
Interrupted or Continuous Slowly Absorbable Sutures For Closure of Primary Elective Midline Abdominal Incisions A Multicenter Randomized Trial (INSECT: ISRCTN24023S41)
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DOI：
10.1097/sla.0b013e31819ec6c8
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发表时间：
2009-04-01
影响因子：
9
通讯作者：
Knaebel, Hanns-Peter
中科院分区：
文献类型：
--
作者：
Seiler, Christoph M.;Bruckner, Thomas;Knaebel, Hanns-Peter
目的：在正中切口手术中，可采用多种材料连续缝合或间断缝合腹筋膜。本研究的目的是比较(1)采用快速可吸收缝线的间断缝合技术和(2)采用不同缓慢可吸收缝线的连续缝合技术，重点观察1年内的切口疝发生率。背景资料摘要：Meta分析表明，采用缓慢可吸收的连续缝合缝线可以更有效地降低切口疝的发生率。患者被安排进行主要的选择性正中切口手术。所有外科医生都接受了培训(连续组缝合伤口长度为4：1)并进行监测。手术后一年内测量的主要终点是经临床检查诊断并经超声证实的切口疝的频率。以并发症和安全性作为次要终点。结果：对625例患者(维克瑞尔间断缝合2 10例，二氧六环式连续缝合205例，单环连续缝合2 10例)进行初步分析，3种缝合技术的术后切口瘘发生率分别为15 9%、8 4%和12 5%(P=0 0 9)。3组在腹部爆裂(4[2.0%]对6[3.0%]对8[4.0%]，P=0.46)、伤口感染(26[12.7%]对39[19.4%]对33[16.3%]，P=0.19)、肺部感染(9[4.4%]对5[2.5%]对5[2.5%]，P=0.46)、严重不良事件(63[30.0%]vs 57[27.8%]vs 61[29.1%]，P=0.89)和1年死亡率(16[7.9%]vs 11[5.5%]vs 16[7.9%]，P=0.54)。需要开发和研究新的概念，以显著减少切口性疝气的发生率。
Objective: In patients undergoing midline incisions, the abdominal fascia can be closed with a continuous or interrupted suture using various materials. The aim of this study is to compare: (1) interrupted technique with rapidly absorbable sutures and (2) continuous techniques with different slowly absorbable sutures, focusing on the incidence of incisional hernias within I year.Summary of Background Data: A meta-analysis suggested that the incidence of incisional hernias can be more effectively reduced with slowly absorbable continuous sutures.Methods: Multicenter randomized surgical trial with 3 parallel groups. Patients were scheduled for primary elective midline incisions. All surgeons were trained (4:1 suture wound length in continuous groups) and monitored. Primary end point, measured within I year after surgery, was the frequency of incisional hernias diagnosed by clinical examination and confirmed by ultrasound. Complications and safety were used as secondary end points. This study has been registered with the ISRCTN Register (INSECT: ISRCTN24023541).Results: Conducted on 625 randomized patients (2 10 interrupted Vicryl, 205 continuous polydioxanone suture (PDS), 2 10 continuous Monoplus), the primary analysis showed an incidence of 28 incisional hernias (15.9%) versus 15 (8.4%) versus 22 (12.5%) for the 3 closure techniques, respectively (P = 0.09). No significant difference was observed between the 3 groups with regard to burst abdomen (4 [2.0%] vs. 6 [3.0%] vs. 8 [4.0%], P = 0.46), wound infection (26 [12.7%] vs. 39 [19.4%] vs. 33 [16.3%], P = 0.19), pulmonary infections (9 [4.4%] vs. 5 [2.5%] vs. 5 [2.5%], P = 0.46), serious adverse events (63 [30.0%] vs. 57 [27.8%] vs. 61 [29.1%], P = 0.89), and 1-year mortality (16 [7.9%] vs. 11 [5.5%] vs. 16 [7.9%], P = 0.54).Conclusions: The incidence of incisional hernias and the frequency of wound infection was higher than expected in all groups. New concepts need to be developed and studied to substantially reduce the frequency of incisional hernias.