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一项评估单丝聚二氧六环酮带刺缝合线(MONOFIX)用于腹部筋膜关闭的安全性和有效性的前瞻性单臂临床试验。

A prospective single-arm clinical trial to assess the safety and efficacy of monofilament polydioxanone barbed suture, MONOFIX, on abdominal fascial closure.

机构信息

Department of Surgery, Eunpyeong St. Mary's Hospital, Catholic University of Korea, Seoul, Korea.

Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

World J Surg. 2024 Jul;48(7):1674-1680. doi: 10.1002/wjs.12247. Epub 2024 Jun 15.

DOI:10.1002/wjs.12247
PMID:38877993
Abstract

BACKGROUND

For abdominal fascial closure, the choice of optimal suture material and appropriate suture technique are of paramount importance to prevent the incidence of incisional hernia. Although barbed sutures are widely used in various surgical fields, their safety and feasibility on abdominal fascial closure which requires the most tensile strength for security have not been established yet.

METHODS

We conducted a prospective, single-arm, interventional clinical trial to present the postoperative outcomes of using barbed sutures in abdominal fascial closure between April 2021 and August 2021. Patients with colorectal cancer who underwent minimally invasive surgery in elective setting were included. For all participants, monofilament polydioxanone barbed suture, MONOFIX, was used to secure the abdominal fasica. The primary outcome was the 1-year incidence of incisional hernia assessed by computed tomography.

RESULTS

A total of 30 patients were included. The median fascial incision length and suture length were 6.5 cm (range, 6-7.5 cm) and 31 cm (range, 27.5-39.0 cm), respectively. The median procedure time of abdominal fascial closure was 4 min (range, 3-9 min). There was no incidence of unexpected event related to suturing including suture cutting, stopper separation from threads, and suture loosening. One case of superficial surgical site infection occurred during postoperative hospital stays. There was no fascial dehiscence, incisional hernia, and adhesive ileus during a median follow-up period of 17.5 months.

CONCLUSION

Monofilament polydioxanone barbed suture, MONOFIX, may be used safely and effectively on abdominal fascial closure.

GOV NUMBER

NCT05872334.

摘要

背景

在腹部筋膜关闭中,选择最佳的缝合材料和合适的缝合技术对于预防切口疝的发生至关重要。尽管带刺缝线在各种外科领域中广泛应用,但它们在腹部筋膜关闭中的安全性和可行性尚未确定,因为腹部筋膜关闭需要最高的张力强度以确保安全。

方法

我们进行了一项前瞻性、单臂、干预性临床试验,以展示 2021 年 4 月至 2021 年 8 月期间使用带刺缝线进行腹部筋膜关闭的术后结果。纳入接受择期微创手术的结直肠癌患者。所有参与者均使用单丝聚二氧杂环已酮带刺缝线 MONOFIX 来固定腹部筋膜。主要结局是通过计算机断层扫描评估的 1 年切口疝发生率。

结果

共纳入 30 例患者。筋膜切口长度和缝线长度的中位数分别为 6.5cm(范围,6-7.5cm)和 31cm(范围,27.5-39.0cm)。腹部筋膜关闭的中位数手术时间为 4 分钟(范围,3-9 分钟)。没有与缝合相关的意外事件发生,包括缝线切割、止动器与缝线分离和缝线松动。1 例患者在术后住院期间发生浅表手术部位感染。在中位数为 17.5 个月的随访期间,没有筋膜裂开、切口疝和粘连性肠梗阻发生。

结论

单丝聚二氧杂环已酮带刺缝线 MONOFIX 可安全有效地用于腹部筋膜关闭。

GOV 编号:NCT05872334。

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