Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial.

Abstract

<h4>Introduction and hypothesis</h4>The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP).<h4>Methods</h4>Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC (n=37) or ASC (n=37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment.<h4>Results</h4>We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0-17; ASC: IQR 0-0) on the "genital prolapse" domain of the Urogenital Distress Inventory in both groups (p = 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% (n = 11) in the LSC group and 84.6% (n = 11) in the ASC group (p = 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%, p = 0.729).<h4>Conclusions</h4>At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages.<h4>Trial registration</h4>Dutch Trial Register NTR6330, 18 January 2017, https://www.trialregister.nl/trial/5964.