Penn Medicine Princeton Medical Center, Princeton, NJ, USA.
Hackensack Meridian Health Medical Group, Old Bridge, NJ, USA.
Int Urogynecol J. 2023 Jul;34(7):1593-1598. doi: 10.1007/s00192-022-05444-7. Epub 2023 Jan 16.
Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System.
An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter).
Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N.
The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.
骶骨固定术（SSL）是一种有效的、广泛应用于矫正子宫顶端脱垂的阴道手术。Saffron 固定系统（美国明尼苏达州明尼阿波利斯市科洛普公司）是一种新的锚固装置，旨在为 SSL 固定提供一种持久、简单、快捷的方法，目标是尽量减少手术并发症。本研究旨在展示使用 Saffron 固定系统进行盆腔器官脱垂修复时锚定部署和缝合固定的疗效和安全性。
进行了一项观察性人体尸体研究，以测量锚定点与骨盆解剖标志之间的距离，以及固定锚的握持力。由不同的植入者将锚放置在四个人体尸体中。测量这些锚的拔出力以评估疗效（三个尸体由三个植入者进行），并测量锚与原始血管和神经之间的距离以评估安全性（一个尸体由一个植入者进行）。
在独立评估中，有 19 个（95%）锚被正确放置。锚与周围神经和血管之间的距离超过 10 毫米。平均（SD）拔出力为 17.9（5.6）N。
开发的创新锚固装置似乎能够实现 SSL 中精确而牢固的锚定。需要进一步的临床研究来探讨该装置的理论优势是否能转化为与现有缝合和锚固装置相比，改善临床结局。
