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Effects of the short stitch technique for midline abdominal closure on incisional hernia (ESTOIH): randomized clinical trial
BJS (British Journal of Surgery) Pub Date : 2022-06-16 , DOI: 10.1093/bjs/znac194
René H Fortelny 1, 2 , Dorian Andrade 3 , Malte Schirren 3 , Petra Baumann 4 , Stefan Riedl 5 , Claudia Reisensohn 5 , Jan Ludolf Kewer 6 , Jessica Hoelderle 6 , Andreas Shamiyeh 7 , Bettina Klugsberger 7 , Theo David Maier 8 , Guido Schumacher 9 , Ferdinand Köckerling 10 , Ursula Pession 11 , Anna Hofmann 1 , Markus Albertsmeier 3
Affiliation  

Abstract Background Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material. Methods A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting. Adult patients were randomly assigned by computer-generated sequence to fascial closure using a short stitch (5 to 8 mm every 5 mm, USP 2-0, single thread HR 26 mm needle) or long stitch technique (10 mm every 10 mm, USP 1, double loop, HR 48 mm needle) with a poly-4-hydroxybutyrate-based suture material (Monomax®). Incisional hernia assessed by ultrasound 1 year after surgery was the primary outcome. Results The trial randomized 425 patients to short (n = 215) or long stitch technique (n = 210) of whom 414 (97.4 per cent) completed 1 year of follow-up. In the short stitch group, the fascia was closed with more stitches (46 (12 s.d.) versus 25 (7 s.d.); P < 0.001) and higher suture-to-wound length ratio (5.3 (2.2 s.d.) versus 4.0 (1.3 s.d.); P < 0.001). At 1 year, seven of 210 (3.3 per cent) patients in the short and 13 of 204 (6.4 per cent) patients in the long stitch group developed incisional hernia (odds ratio 1.97, 95 per cent confidence interval 0.77 to 5.05; P = 0.173). Conclusion The 1-year incisional hernia development was relatively low with clinical but not statistical difference between short and long stitches. Registration number: NCT01965249 (http://www.clinicaltrials.gov)

中文翻译:

短缝技术对腹部中线闭合对切口疝 (ESTOIH) 的影响:随机临床试验

摘要 背景切口疝仍然是中线剖腹手术后的常见问题。这项研究使用超长期吸收性弹性缝合材料将短缝线与标准环闭合进行了比较。 方法为选择性环境设计了一项前瞻性、多中心、平行组、双盲、随机、对照优效性试验。根据计算机生成的序列,将成年患者随机分配至筋膜闭合组,使用短缝线(每 5 毫米 5 至 8 毫米,USP 2-0,单线 HR 26 毫米针)或长缝线技术(每 10 毫米 10 毫米,USP 1、双环、HR 48 毫米针),采用聚 4-羟基丁酸酯缝合材料 (Monomax®)。主要结局是术后 1 年通过超声评估切口疝。 结果该试验将 425 名患者随机分为短缝技术 (n = 215) 或长缝技术 (n = 210),其中 414 人 (97.4%) 完成了 1 年的随访。在短缝组中,用更多的缝线(46(12 sd)对比 25(7 sd);P < 0.001)和更高的缝线与伤口长度比(5.3(2.2 sd)对比 4.0(1.3标准差);P<0.001)。第 1 年时,短缝组 210 名患者中有 7 名(3.3%)发生切口疝,长缝组 204 名患者中有 13 名(6.4%)发生切口疝(比值比 1.97,95% 置信区间 0.77 至 5.05;P = 0.173)。 结论1 年切口疝发生率相对较低,短缝线和长缝线之间存在临床差异,但无统计学差异。注册号:NCT01965249 (http://www.clinicaltrials.gov)
更新日期:2022-06-16
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