Abstract：
OBJECTIVE: Sacrospinous ligament fixation (SSLF) is a popular surgical technique for treating apical prolapse. The use of suture-capturing devices (SCD), or the more recently introduced anchor-based device (ABD), is useful for a posterior approach but essential for an anterior one. The aim of our study was to assess the safety of the ABD, which was recently introduced to our unit, compared to the traditionally used SCD.
METHODS: This was a pilot case-control study of 40 patients who had a SSLF, 20 of these represented all the patients who had the procedure with the aid of the ABD and 20 patients who had the procedure using the SCD over approximately the same duration. The main safety endpoints of this pilot study were patient reported postoperative pain scores and perioperative complications rate.
RESULTS: The population characteristics were similar. The mean postoperative pain scores differed significantly only on postoperative day 1 in favor of the suture capturing device (3.40 [2.60] vs 1.60 [1.64], p = 0.013). The mean highest pain score was similar in both groups. Peri-operative complications rates were low and comparable between both groups. According to POPQ at 6 weeks follow-up the median Ba point was higher in the ABD group and this difference was significant (-3.00 [-3.00; -2.25] vs. -2.00 [-3.00; -1.50]; p = 0.03).
CONCLUSIONS: The anchor-based device for sacrospinal ligament fixation seems to have comparable safety profile to the traditionally used suture capturing devices.
METHODS: This was a pilot case-control study of 40 patients who had a SSLF, 20 of these represented all the patients who had the procedure with the aid of the ABD and 20 patients who had the procedure using the SCD over approximately the same duration. The main safety endpoints of this pilot study were patient reported postoperative pain scores and perioperative complications rate.
RESULTS: The population characteristics were similar. The mean postoperative pain scores differed significantly only on postoperative day 1 in favor of the suture capturing device (3.40 [2.60] vs 1.60 [1.64], p = 0.013). The mean highest pain score was similar in both groups. Peri-operative complications rates were low and comparable between both groups. According to POPQ at 6 weeks follow-up the median Ba point was higher in the ABD group and this difference was significant (-3.00 [-3.00; -2.25] vs. -2.00 [-3.00; -1.50]; p = 0.03).
CONCLUSIONS: The anchor-based device for sacrospinal ligament fixation seems to have comparable safety profile to the traditionally used suture capturing devices.
摘要：
目的：骶棘韧带固定术（SSLF）是治疗根尖脱垂的一种常用外科技术。缝线捕获装置（SCD）的使用，或者最近推出的基于锚的设备(ABD)，对于后路是有用的，但对于前路是必不可少的。我们研究的目的是评估ABD的安全性，最近被介绍给我们单位，与传统使用的SCD相比。
方法：这是一项针对40例SSLF患者的试点病例对照研究，其中20个代表在ABD的帮助下进行手术的所有患者和在大约相同的持续时间内使用SCD进行手术的20个患者。这项初步研究的主要安全性终点是患者报告的术后疼痛评分和围手术期并发症发生率。
结果：人群特征相似。平均术后疼痛评分仅在术后第1天显着差异，有利于缝合捕获装置（3.40[2.60]vs1.60[1.64]，p=0.013)。两组的平均最高疼痛评分相似。围手术期并发症发生率较低，两组之间具有可比性。根据POPQ，在6周随访时，ABD组的中位数Ba点更高，并且这种差异是显着的（-3.00[-3.00;-2.25]vs.-2.00[-3.00;-1.50];p=0.03)。
结论：基于锚钉的骶脊髓韧带固定装置似乎具有与传统使用的缝线捕获装置相当的安全性。
方法：这是一项针对40例SSLF患者的试点病例对照研究，其中20个代表在ABD的帮助下进行手术的所有患者和在大约相同的持续时间内使用SCD进行手术的20个患者。这项初步研究的主要安全性终点是患者报告的术后疼痛评分和围手术期并发症发生率。
结果：人群特征相似。平均术后疼痛评分仅在术后第1天显着差异，有利于缝合捕获装置（3.40[2.60]vs1.60[1.64]，p=0.013)。两组的平均最高疼痛评分相似。围手术期并发症发生率较低，两组之间具有可比性。根据POPQ，在6周随访时，ABD组的中位数Ba点更高，并且这种差异是显着的（-3.00[-3.00;-2.25]vs.-2.00[-3.00;-1.50];p=0.03)。
结论：基于锚钉的骶脊髓韧带固定装置似乎具有与传统使用的缝线捕获装置相当的安全性。
