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

作者：Freeman R M^*; Pantazis K; Thomson A; Frappell J; Bombieri L; Moran P; Slack M; Scott P; Waterfield M

来源：International Urogynecology Journal and Pelvic Floor Dysfunction, 2013, 24(3): 377-384.

DOI：10.1007/s00192-012-1885-x

• Open and laparoscopic sacrocolpopexy
• Equivalence trial
• Quality of life
• Further surgery
• Occult urinary incontinence
• Complications

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

• 出版日期2013-3