HIBISCUS试验 (连续刺刺的发生率与小切口结直肠外科手术中断的 suturing):一个多中心随机对照试验的当代研究协议
Yushi Yamakawa1, Hiroki Takahashi2, Kazuyoshi Shiga3
1Department of Gastroenterological Surgery, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467- 8601, Japan. y-yamaka@med.nagoya-cu.ac.jp.
BMC surgery
|January 26, 2026
概括
这项研究比较了在结肠直肠癌手术中用于切口预防的连续刺针和中断接. 结果将指导在最小侵入性手术中最佳的关闭技术.
科学领域:
- 手术瘤学手术瘤学
- 最少侵入性的手术
- 腹壁的重建 腹壁的重建
背景情况:
- 切口是腹部手术后的常见并发症,特别是微创性结肠直肠手术.
- 目前的日本小中线切口的做法通常涉及中断接,但将其与连续刺针接相比较的证据有限.
- 缺乏关于腹腔镜和机器人辅助结直肠手术连续关闭的随机数据.
研究的目的:
- 为了确定连续刺针接是否优于常规中断接在预防微创性结直肠癌手术后的切口.
- 在这个患者群体中提供优质的关闭技术的高质量证据.
主要方法:
- HIBISCUS试验是一项多中心,前性,随机对照性研究,用于比较连续刺针 (STRATAFIX对称PDS Plus) 和中断单丝 (PDS Plus) 合用于关闭.
- 符合条件的结肠直肠癌患者接受选择性腹腔镜或机器人辅助切除将被随机分配1:1.
- 主要终点是18个月内切割性发生率,通过CT成像和临床检查进行评估. 将验证外科医生的能力.
主要成果:
- 该部分尚未提供,因为研究仍在进行中.
- 该研究旨在招募422名患者,以确保足够的统计能力.
- 二级终点包括关闭时间,伤口并发症 (例如手术部位感染),疼痛和重新手术率.
结论:
- 这项试验是第一个随机研究,直接比较在微创性结直肠外科手术中小中线切口的连续刺针和中断 suturing.
- 标准化参数和外科医生的能力验证旨在产生高质量的证据.
- 预期的结果可能会影响临床实践,指导方针的制定和腹壁关闭的全球标准化.
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