PDF(Pubmed)
Abstract：
BACKGROUND: The recent guidelines from the European and American Hernia Societies recommend a continuous small-bite suturing technique with slowly absorbable sutures for fascial closure of midline abdominal wall incisions to reduce the incidence of wound complications, especially for incisional hernia. However, this is based on low-certainty evidence. We could not find any recommendations for skin closure. The wound closure technique is an important determinant of the risk of wound complications, and a comprehensive approach to prevent wound complications should be developed.
METHODS: We propose a single-institute, prospective, randomized, blinded-endpoint trial to assess the superiority of the combination of continuous suturing of the fascia without peritoneal closure and continuous suturing of the subcuticular tissue (study group) over that of interrupted suturing of the fascia together with the peritoneum and interrupted suturing of the subcuticular tissue (control group) for reducing the incidence of midline abdominal wall incision wound complications after elective gastroenterological surgery with a clean-contaminated wound. Permuted-block randomization with an allocation ratio of 1:1 and blocking will be used. We hypothesize that the study group will show a 50% reduction in the incidence of wound complications. The target number of cases is set at 284. The primary outcome is the incidence of wound complications, including incisional surgical site infection, hemorrhage, seroma, wound dehiscence within 30 days after surgery, and incisional hernia at approximately 1 year after surgery.
CONCLUSIONS: This trial will provide initial evidence on the ideal combination of fascial and skin closure for midline abdominal wall incision to reduce the incidence of overall postoperative wound complications after gastroenterological surgery with a clean-contaminated wound. This trial is expected to generate high-quality evidence that supports the current guidelines for the closure of abdominal wall incisions from the European and American Hernia Societies and to contribute to their next updates.
BACKGROUND: UMIN-CTR UMIN000048442. Registered on 1 August 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205.
METHODS: We propose a single-institute, prospective, randomized, blinded-endpoint trial to assess the superiority of the combination of continuous suturing of the fascia without peritoneal closure and continuous suturing of the subcuticular tissue (study group) over that of interrupted suturing of the fascia together with the peritoneum and interrupted suturing of the subcuticular tissue (control group) for reducing the incidence of midline abdominal wall incision wound complications after elective gastroenterological surgery with a clean-contaminated wound. Permuted-block randomization with an allocation ratio of 1:1 and blocking will be used. We hypothesize that the study group will show a 50% reduction in the incidence of wound complications. The target number of cases is set at 284. The primary outcome is the incidence of wound complications, including incisional surgical site infection, hemorrhage, seroma, wound dehiscence within 30 days after surgery, and incisional hernia at approximately 1 year after surgery.
CONCLUSIONS: This trial will provide initial evidence on the ideal combination of fascial and skin closure for midline abdominal wall incision to reduce the incidence of overall postoperative wound complications after gastroenterological surgery with a clean-contaminated wound. This trial is expected to generate high-quality evidence that supports the current guidelines for the closure of abdominal wall incisions from the European and American Hernia Societies and to contribute to their next updates.
BACKGROUND: UMIN-CTR UMIN000048442. Registered on 1 August 2022. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055205.
摘要：
背景：欧洲和美国疝协会最近的指南推荐了一种连续的小咬合缝合技术，该技术具有缓慢吸收的缝合线，用于闭合中线腹壁切口的筋膜，以减少伤口并发症的发生率，尤其是切口疝.然而,这是基于低确定性的证据。我们找不到任何关闭皮肤的建议。伤口闭合技术是伤口并发症风险的重要决定因素，应制定预防伤口并发症的综合方法。
方法：我们提出了一个单一的研究所，prospective,随机化，盲法-终点试验旨在评估不闭合腹膜的筋膜连续缝合和表皮下组织连续缝合（研究组）在减少选择性胃肠手术和清洁污染伤口后中线腹壁切口并发症发生率方面的优越性。将使用分配比率为1:1和阻塞的置换块随机化。我们假设研究组将显示伤口并发症的发生率降低50％。病例的目标数量设定在284。主要结果是伤口并发症的发生率，包括手术切口感染,出血,血清肿,手术后30天内伤口裂开，手术后大约1年的切口疝。
结论：该试验将为中线腹壁切口筋膜和皮肤闭合的理想组合提供初步证据，以减少清洁污染伤口的胃肠手术后整体术后伤口并发症的发生率。预计该试验将产生高质量的证据，以支持欧洲和美国疝协会关于关闭腹壁切口的当前指南，并有助于他们的下一次更新。
背景：UMIN-CTRUMIN000048442.2022年8月1日注册https://center6.乌明。AC.jp/cgi-open-bin/ctr_e/ctr_view。cgi?recptno=R000055205。
方法：我们提出了一个单一的研究所，prospective,随机化，盲法-终点试验旨在评估不闭合腹膜的筋膜连续缝合和表皮下组织连续缝合（研究组）在减少选择性胃肠手术和清洁污染伤口后中线腹壁切口并发症发生率方面的优越性。将使用分配比率为1:1和阻塞的置换块随机化。我们假设研究组将显示伤口并发症的发生率降低50％。病例的目标数量设定在284。主要结果是伤口并发症的发生率，包括手术切口感染,出血,血清肿,手术后30天内伤口裂开，手术后大约1年的切口疝。
结论：该试验将为中线腹壁切口筋膜和皮肤闭合的理想组合提供初步证据，以减少清洁污染伤口的胃肠手术后整体术后伤口并发症的发生率。预计该试验将产生高质量的证据，以支持欧洲和美国疝协会关于关闭腹壁切口的当前指南，并有助于他们的下一次更新。
背景：UMIN-CTRUMIN000048442.2022年8月1日注册https://center6.乌明。AC.jp/cgi-open-bin/ctr_e/ctr_view。cgi?recptno=R000055205。
