一个可行性和安全性试验,研究一种用于快速和标准化的中腹切割闭关装置
Gabriel Börner1,2, Lena Toft3, Peder Rogmark4,5
1Department of Clinical Sciences Lund, Lund University, Lund, Sweden. gabriel.borner@med.lu.se.
概括
一个新的SutureTOOL设备使标准化的中线腹腔切除术闭合成为可能,在所有患者中实现最佳的长度比率. 这种安全快速的设备为外科医生展示了一个简短的学习曲线.
科学领域:
- 手术方面的创新.
- 腹壁关闭技术 腹壁关闭技术
- 医疗器械开发 医疗器械开发
背景情况:
- 中线腹腔切除术关闭并发症可以通过遵守指导方针来减少.
- 在临床实践中,实施这些指导方针可能具有挑战性.
- 开发了一种新的腹腔切除关闭装置,以解决标准化和速度问题.
研究的目的:
- 评估新型腹腔切除关闭装置的临床安全性,速度和质量.
- 评估实现长与伤口长度比率 (SL/WL) ≥4的可行性.
- 为了确定设备对操作时间和不良事件的影响.
主要方法:
- 一项前性,单臂研究,涉及五名外科医生和38名因结肠直肠疾病而接受腹腔切除术的患者.
- 外科医生接受了设备的培训,包括干实验室实践.
- 主要终点:SL/WL比率≥4的患者比例. 二级终点:接时间,手套穿孔,手术部位感染 (SSI) 和腹部破裂.
主要成果:
- 所有患者都实现了主要终点 (SL/WL比率≥4).
- 平均接时间为10.5分钟;平均净关闭时间 (NCT) 为7.4分钟.
- 没有发生手套穿孔;报告了一次SSI;没有观察到腹部破裂病例. 在第三次关闭后,学习曲线稳定.
结论:
- 该SutureTOOL设备是临床腹腔切除关闭的一个有前途的创新.
- 该设备被认为是安全的,用户友好和快速的,学习曲线很短.
- 未来的多中心随机试验有必要评估其对短期和长期并发症的影响.
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