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- Title
A randomised controlled trial of abdominal versus laparoscopic sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study.
- Authors
Freeman, R.; Pantazis, K.; Thomson, A.; Frappell, J.; Bombieri, L.; Moran, P.; Slack, M.; Scott, P.; Waterfield, M.
- 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.
- Subjects
LAPAROSCOPY; UROGYNECOLOGY; UTERINE prolapse; VAGINAL diseases; HYMEN (Gynecology)
- Publication
International Urogynecology Journal, 2013, Vol 24, Issue 3, p377
- ISSN
0937-3462
- Publication type
Article
- DOI
10.1007/s00192-012-1885-x