BEST: Barbed-Suture Efficiency Study for Sacrocolpopexy: A Randomized Clinical Trial

INTRODUCTION: During robotic-assisted sacrocolpopexy (SCP), increasing the surgical efficiency of mesh attachment may lead to decreased surgical time and cost. No data exists to compare unidirectional delayed-absorbable barbed suture to non-barbed delayed absorbable suture for patients undergoing robotic SCP. OBJECTIVE: The primary objective was to determine if unidirectional barbed suture results in a 50% faster vaginal mesh attachment compared to non-barbed suture for surgeons performing robotic SCP. The secondary objectives were to compare total operative time, mesh attachment time by surgeon experience, and surgeon satisfaction with suture type. METHODS: A single-blind, randomized trial of women undergoing robotic SCP for ≥stage II symptomatic pelvic organ prolapse was performed. Women were randomized to 2-0 absorbable, monofilament barbed suture (9 inch, GS22 needle) versus 2-0 non-barbed, absorbable, monofilament suture (polydioxanone) for vaginal attachment of a lightweight polypropylene y-mesh. The primary outcome was the total time for vaginal mesh attachment. The secondary outcome was total operative time between the groups. In addition, surgical time by level of training was calculated (resident, fellow, or attending). Finally, surgeon satisfaction with ease of mesh attachment, appearance of mesh, and global satisfaction with suture was assessed with a 10-point visual analog scale (VAS). A score of 10 indicated the greatest ease, appearance, and satisfaction. Data was analyzed per protocol. Demographics, medical and surgical history, surgical details, postoperative data, and adverse events were recorded. A power calculation estimated that a total of 23 participants per group were needed to determine if unidirectional barbed suture decreases vaginal mesh attachment time by 50%, assuming a 5% significance level and 80% power. RESULTS: Between 7/2023 through 10/2024, 46 subjects were included in the study: 23 had barbed suture and 23 had non-barbed suture used for vaginal mesh attachment. There were no preoperative differences between groups. Mean time for vaginal mesh attachment was 13.2 min (±3.8 min) for barbed suture and 20.4 min (±6.0 min) for non-barbed suture (p=<0.01) (Table 1). While this was statistically significant, this did not reach the primary outcome of 50% decrease in suture time. Resident surgeons had a greater difference in suture time compared to fellows and attendings. Surgeons rated global satisfaction higher with barbed suture (9.0 vs 7.8, p<0.01) (Figure 1). Ease of mesh attachment and appearance of the mesh were rated similarly between barbed and non-barbed sutures. There was similar total operative time (180 vs 187 min, p=0.52), estimated blood loss, and intraoperative complications between the groups. At 6-month follow-up, there was one mesh exposure in each group that was treated with partial mesh excision. CONCLUSIONS: Unidirectional barbed suture decreased mesh attachment time compared to non-barbed delayed-absorbable suture especially for inexperienced surgeons. Overall, surgeon satisfaction was higher for barbed suture.