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Study Objective To demonstrate the non-inferiority of delayed absorbable sutures compared to non-absorbable sutures in laparoscopic sacrocolpopexy (LSC) for correction of pelvic organ prolapse. Design It is a randomized 1:1 non-inferiority surgical clinical trial (NCT03582410). Setting Obstetric and Gynecological Department of “Ospedale Regionale F. Miulli”. Patients or Participants 160 patients, who required surgical treatment for symptomatic prolapse were assessed for eligibility. 6 patients declined to participate and 4 patients did not meet inclusion criteria. 150 patients were enrolled and all completed follow up. Interventions Patients were randomized to receive LSC with delayed absorbable (group A: 75 patients) and non-absorbable sutures (group B: 75 patients) for anterior and posterior mesh fixation to vagina. Primary outcome was the correction of the prolapse at 1, 6 and 12 months after surgery. Intraoperative parameters, intraoperative and postoperative characteristics and long term morbidity were considered as secondary outcomes. Measurements and Main Results Baseline characteristics were comparable between groups. There were no differences in terms of blood loss, operation time, intraoperative complications. No cases of failure and no differences in terms of prolapse correction were observed. There was bowel symptoms gradual reduction in both groups. Rate of de novo urinary incontinence and persistent urinary incontinence after 12 months was similar (respectively 7% in group A vs 5% in group B, p: 1,00 and 11 %in group A vs 5% in group B, p: 0,229). Rate of mesh erosion at 12 months was higher in group B though not statistically significant (4% vs 0%, p:0,24). Conclusion Delayed absorbable sutures are comparable to non-absorbable sutures for mesh fixation in LSC in terms of success of procedure, operative parameters, intraoperative and post-operative characteristics. Other studies are needed to clarify if absorbable sutures can be associated to a decreased rate of mesh erosions. |
