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Randomized Controlled Trial
. 2023 Nov;130(12):1542-1551.
doi: 10.1111/1471-0528.17525. Epub 2023 May 2.

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

Anique M J van Oudheusden  1   2 , Mèlanie N van IJsselmuiden  2   3 , Leah F Menge  4 , Anne-Lotte W M Coolen  5 , Joggem Veen  6 , Hugo W F van Eijndhoven  3 , Viviane Dietz  7 , Kirsten B Kluivers  8 , Wilbert A Spaans  9 , Astrid Vollebregt  10 , Geerte van de Pol  11 , Celine M Radder  12 , J Marinus van der Ploeg  13 , Sander M J van Kuijk  14 , Marlies Y Bongers  2   6
Affiliations
Randomized Controlled Trial

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

Anique M J van Oudheusden et al. BJOG. 2023 Nov.

Abstract

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.

Keywords: apical prolapse; laparoscopic sacrocolpopexy; sacrospinous colpopexy; vaginal sacrospinous fixation; vaginal vault prolapse.

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References

REFERENCES

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