A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study

Int Urogynecol J. 2013 Mar;24(3):377-84. doi: 10.1007/s00192-012-1885-x. Epub 2012 Aug 3.

Abstract

Introduction and hypothesis: This prospective multi-centre true two-sided equivalence trial was designed to test the clinical equivalence of open (ASCP) and laparoscopic (LSCP) sacrocolpopexy using objective and subjective outcomes

Methods: The study was carried out in three urogynaecology units in England, UK and the patient population consisted of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions were either abdominal or laparoscopic sacrocolpopexy following randomisation to one of the types of surgery.

Results: For the primary outcome (point C on the POP-Q) the results at 1 year were -6.63 cm for the open ASCP and -6.67 cm for the LSCP respectively. Subjective outcomes at 1 year showed that 90% of the ASCP group and 80% of the LSCP group were "much better". There were improvements with regard to blood loss, haemoglobin and shorter length of stay in the LSCP group compared with the ASCP group.

Conclusion: This fully powered randomised controlled trial comparing open and laparoscopic sacrocolpopexy has shown clinical equivalence.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdomen / surgery*
  • Aged
  • Blood Loss, Surgical
  • Colposcopy / methods*
  • England
  • Female
  • Follow-Up Studies
  • Humans
  • Laparoscopy / methods*
  • Length of Stay
  • Middle Aged
  • Pelvic Organ Prolapse / surgery*
  • Prospective Studies
  • Treatment Outcome