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)
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
中文摘要
切口疝是腹直视手术后最常见的并发症之一,在随机对照试验(RCTs)中经常报道其发生率为10-30%。his造成大量发病率、成本、生活质量和死亡率的降低。在德国,每年有超过51,000例切口疝修补手术,复发率高达30%,令人无法接受。因此,预防IHs至关重要。最近,提出了两项技术进展来减少切口疝的形成:a)小针缝合腹壁技术和b)预防性补片植入。与传统的大咬合技术相比,小缝线缝合腹壁技术增加了用于缝合腹壁的针数,从而将缝线长度与伤口长度之比提高到4以上。同样,在初次手术时预防性补片植入被证明可以减少特定亚群患者的切口疝形成。最近的一项多中心随机对照试验报告,切口疝发生率在两年后低至13%。最重要的是,预防性补片组没有增加其他具有临床意义的伤口并发症。然而,以前从未有过预防性补片放置与有前途的小缝线技术相结合的情况。因此,HULC试验将调查这两种技术的结合是否会导致切口疝的额外减少。
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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国内基金
海外基金
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依托单位: