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Hernia reduction following laparotmy using small stitch abdominal wall closure with or without mesh augmentration (HULC)

Hernia reduction following laparotmy using small stitch abdominal wall closure with or without mesh augmentration (HULC)
剖腹手术后使用小缝腹壁闭合带或不带补片 (HULC) 减少疝气
批准号:
410901776
负责人:
Professor Dr. Andre Mihaljevic
金额:
$0.0万
依托单位国家:
德国
项目类别:
Clinical Trials
财政年份:
2019
资助国家:
德国
项目状态:
已结题
起止时间:
2018-12-31 至 2023-12-31

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中文摘要
翻译
切口疝气是开腹手术后最常见的并发症之一,在随机对照试验(RCT)中经常报道其发生率为10-30%。IHS导致相当大的发病率、成本、生活质量下降和死亡率。在德国,每年有超过51,000例的腹股沟切口修补手术,复发率高达30%,令人难以接受。因此,预防IHS是至关重要的。最近,有两项技术进步被提出以减少切口疝的形成:a。腹壁缝合小针法及b.)预防性网片植入。与传统的大咬合闭合技术相比,腹壁闭合的小缝合技术增加了用于闭合腹壁的缝合次数,从而使缝合长度与伤口长度的比率增加到4以上。类似地,在初次手术时植入预防性网片可以减少特定亚组患者的切口疝气的形成。最近的一项多中心随机对照试验报告说,两年后的切口率低至13%。最重要的是,预防性网片组的其他临床显著伤口并发症并未增加。然而,在此之前,预防性网片放置从未与前景看好的小缝合技术相结合。因此,HULC试验将调查这两种技术的结合是否能进一步减少切口疝。
英文摘要
Incisional hernias are one of the most frequent complications following open abdominal surgery with rates of 10-30% being regularly reported in randomized controlled trials (RCTs). IHs cause substantial morbidity, costs, reduction in quality of life and mortality. More than 51,000 incisional hernia repairs are performed in Germany each year with unacceptable high recurrence rates of up to 30%. Therefore, prevention of IHs is of utmost importance. Recently, two technical advances were proposed to reduce incisional hernia formation: a.) closure of the abdominal wall in small stitch technique and b.) prophylactic mesh implantation. Small stitches technique for abdominal wall closure increases the number of stitches used to close the abdominal wall in comparison to traditional large bite closure techniques, thereby increasing the suture-length to wound-length ratio to over four. Similarly, prophylactic mesh implantation at the time of primary surgery was shown to reduce incisional hernia formation in specific subsets of patients. A recent multicentre RCT reported incisional hernia rates as low as 13% after two years. Most importantly, other clinically significant wound complications were not increased in the prophylactic mesh group. However, never before prophylactic mesh placement has been combined with the promising small stitches technique. Thus, the HULC trial will investigate whether a combination of these two techniques leads to an additional reduction of incisional hernias.
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