The criterion standard for posthysterectomy vaginal vault prolapse is abdominal sacrocolpopexy. A laparoscopic approach has potential advantages of reduced morbidity, shorter hospital stay, and convalescence. The popularity of this approach to the procedure is increasing among patients and surgeons. Results were comparable for open and laparoscopic sacrocolpopexy in several case reports, but no randomized controlled trials have compared the 2 techniques.
This prospective multicenter 2-sided equivalence trial compared the clinical equivalence of open and laparoscopic sacrocolpopexy using objective and subjective outcomes. The study was conducted in 3 urogynecology units in the United Kingdom. Participants were postmenopausal women with symptomatic and bothersome vaginal vault prolapse of at least stage II using the Pelvic Organ Prolapse Quantitation (POP-Q) system. This means the leading edge of the prolapse during Valsalva protruded at least to 1 cm above the hymen. Either the open or laparoscopic procedure was performed following randomization to one of the types of surgery. The primary study outcome measures were the quantitative description of point C on the POP-Q system and the subjective Patient Global Impression of Improvement at 1 year.
For the primary outcome, the change from baseline values for point C on the POP-Q was −6.63 cm for the open procedure and −6.67 cm for the laparoscopy at 1 year. Subjective outcomes with both procedures were much better or very much better at 1 year: 90% and 80% for open surgery and the laparoscopic procedure, respectively. Improvements in secondary outcomes (less blood loss, reduction in hemoglobin concentration, and shorter length of stay) were greater with the laparoscopic procedure.
These findings show that sacrocolpopexy can be performed either by an open or a laparoscopic procedure with clinically equivalent outcomes.
Urogynaecology Unit, Directorate of Women’s Health, Derriford Hospital, Plymouth PL6 8DH, UK (R.M.F., K.P., L.B., M.W.); Minimal Access Surgery Group, Plymouth Hospitals NHS Trust, Plymouth, UK (J.F., P.S.); Worcestershire Acute Hospitals NHS Trust, Worcester, UK (A.T., P.M.); Addenbrooke’s Hospital Univ. of Cambridge, Teaching Hospital Trust, Cambridge, UK (M.S.); Peninsula College of Medicine and Dentistry, Plymouth (R.M.F., M.W.).