Safety of an anchor-based device for sacrospinous ligament fixation: A pilot case-control study.

INTRODUCTION AND HYPOTHESIS: 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). CONCLUSION: The anchor-based device for sacrospinal ligament fixation seems to have comparable safety profile to the traditionally used suture capturing devices.

Anterior Bilateral Sacrospinous Fixation With Transvaginal Mesh: Is Hysterectomy a Risk Factor for Complications?

OBJECTIVES: The aim of the study was to evaluate the effect of hysterectomy on the risk of complications from transvaginal pelvic organ prolapse surgery with mesh. METHODS: We conducted a retrospective cohort study between October 2010 and December 2017. Transvaginal mesh surgery was performed in patients with symptomatic anterior and/or apical prolapse (Pelvic Organ Prolapse Quantification ≥ stage 2). The primary outcome was rate of severe surgical complications based on the Clavien-Dindo classification (defined as grade ≥3), and the secondary outcome was the anatomical success at the last postoperative follow-up visit. RESULTS: Three hundred and ninety-six patients were included, 289 of these patients underwent anterior sacrospinous fixation with uterine preservation, 50 had a previous hysterectomy and 57 underwent a concomitant hysterectomy. The median follow-up was 12 months (interquartile range, 7 months). The rate of severe complications was 2.1%, 6.0%, and 5.3% in the uterine preservation group, previous hysterectomy group, and concomitant hysterectomy group, respectively (P = 0.2). The operative time was significantly higher in the concomitant hysterectomy group, and the mesh exposure rate was significantly higher in the previous hysterectomy group. The overall recurrence rate was 7.6%, with no differences between the study groups. CONCLUSIONS: Concomitant and previous hysterectomy did not appear to increase the severe complication rate or anatomical failure after transvaginal mesh surgery. However, a history of hysterectomy appears to be a risk factor for vaginal mesh exposure. This must be considered in the choice between prosthetic and autologous management options for the treatment of posthysterectomy vault prolapse.