LAUSR

BACKGROUND Vaginal mesh attachment can be one of the most time intensive components of minimally invasive sacrocolpopexy. OBJECTIVE To assess the impact on the duration of surgery of using absorbable anchors compared to interrupted sutures for vaginal mesh attachment in robotic-assisted sacrocolpopexy. STUDY DESIGN This is a single-masked, randomized clinical trial at 2 clinical sites in women with pelvic organ prolapse undergoing robotic-assisted sacrocolpopexy. Participants were randomized to either interrupted delayed-absorbable anchors or sutures for the vaginal mesh attachment portion of the case. Participants completed validated questionnaires at baseline, 6 weeks, 6 months, and 12 months after surgery. A certified examiner masked to the treatment arm performed a clinical examination with assessment of POPQ, mesh exposure, and overall appearance of vaginal walls using a 10-cm visual analog scale at each follow-up visit. The primary outcome was the vaginal mesh attachment time. Categorical variables were compared using chi-square or Fischer's Exact test, whereas continuous variables were compared using Student's t test or Mann-Whitney U test as appropriate. An intention-to-treat analysis was performed. RESULTS Fifty-three participants were randomized, 26 to mesh attachment with anchor, 27 to mesh attachment with suture, and 81% (21/26) and 93% (25/27) had 12-month follow up respectively. There were no significant differences between groups in age (p=0.12), BMI (p=0.23), stage of prolapse (p=0.97), or other preoperative factors. Mesh attachment interval time was faster in the anchor compared to suturing arm (12.2±7.8 vs. 21.2± 5.2 min, p<0.001), while sacrocolpopexy times (107.6± 33.2 vs 109.8± 21.2, p=0.774) were not different. VAS for surgeon ease of placement (p=0.16), appearance of mesh attachment (p=0.07), and global satisfaction with use of attachment type (p=0.65) were similar between the arms. There was no difference in perioperative adverse events rates between arms and by 12 months follow-up there were no sacrocolpopexy mesh, anchor, or suture exposures. There was no difference in outcomes at 12 months including composite failure (10% vs 12%, p=0.79), patient global impression of improvement (1.06 vs. 1.19, p=0.27), or patient pelvic pain (9.81 vs. 9.67, p=0.56). CONCLUSIONS In patients undergoing robotic-assisted sacrocolpopexy the anchor vaginal mesh attachment technique required significantly less time than suturing. There was no difference between techniques in complications, failure, surgeon or patient-reported outcomes through 12 months of follow-up. Mesh attachment during sacrocolpopexy can be performed in less time using the anchor technique, providing surgeons another surgical technique for this procedure.