Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO‐2 trial).

Objective: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP‐Q stage ≥2 vaginal vault prolapse (VVP). Design: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. Setting: Seven non‐university teaching hospitals and two university hospitals in the Netherlands. Population: Patients with symptomatic post‐hysterectomy vaginal vault prolapse, requiring surgical treatment. Methods: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP‐Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. Main outcome measures: Primary outcome was disease‐specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri‐operative data, complications and sexual function. Results: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease‐specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). Conclusions: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow‐up period of 12 months. [ABSTRACT FROM AUTHOR]