You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology1 Apr 2015MP81-18 ABDOMINAL VS LAPAROSCOPIC SACROCOLPOPEXY: A RANDOMIZED CONTROLLED TRIAL Manuel Di Biase, Luigi Mearini, Alessandro Zucchi, Michele Del Zingaro, Amelia Pietropaolo, Eleonora Salvini, Antonella Giannantoni, and Elisabetta Costantini Manuel Di BiaseManuel Di Biase More articles by this author , Luigi MeariniLuigi Mearini More articles by this author , Alessandro ZucchiAlessandro Zucchi More articles by this author , Michele Del ZingaroMichele Del Zingaro More articles by this author , Amelia PietropaoloAmelia Pietropaolo More articles by this author , Eleonora SalviniEleonora Salvini More articles by this author , Antonella GiannantoniAntonella Giannantoni More articles by this author , and Elisabetta CostantiniElisabetta Costantini More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2896AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Aim of this prospective randomized controlled trial is to compare Abdominal (AS) versus Laparoscopic sacropexy (LS) in women with advanced pelvic organ prolapse (POP) to demonstrate the effective role of LS in POP repair METHODS Consecutive patients affected by symptomatic POP stage>II according to the POP-q classification were prospectively randomized, the trial was registered as Clinical trial NCT01182090. The primary objective was to test the clinical equivalence of AS and LS through the quantitative description of point C/D. The secondary outcome was assessment of how much better LS was than AS in terms of complications, morbidity, operating time, intra-operative blood loss, length of hospital stay and post-operative complications. A sample size of 60 patients per group, at p=0.05, two-sided t test was estimated to have 90% power to reject the null hypothesis that the laparoscopic and open methods are not equivalent (with a pre-specified tolerance limit margin of 0.5 cm for equivalence with a common SD of 0.8 cm). The Mann-Whitney and Chi square tests were used for statistical analysis RESULTS 121 patients have been randomized. 1 patient from the LS group and 1 from AS group were lost to f-up, 1 patient in the LS group was converted so finally we evaluated 58 pts in the LS arm and 60 in the AS arm. The median follow-up was 32,53 months (range 16–56 months). Operating time was longer for LS (mean 121 min for AS vs 219 min for LS, p<0.001). Intra-operative blood loss was higher in AS (mean 245 ml for AS vs 99,13 ml for LS, p<0.001) and hospital stays were longer (mean 5.8 days for AS vs 4.4 days for LS, p<0.001). The complications according to the Clavien-Dindo classification were 14 in the AS arm and 13 in the LS arm for the grade I (p= 0,15), 11 in the AS group Vs 1 in the LS group for the grade II (p=0,02) and 1 in the AS group Vs 4 in the LS group for the grade III (p=0,017). Tab I shows the mean post- operative point C/D evaluation for both techniques. No apical prolapse in both groups recurred, asymptomatic stage I–II recurrence was reported in 10% in AS vs 24.1% in LS (p=0.051) CONCLUSIONS These data show LS provide outcomes as good as AS with decreased morbidity, less blood loss and shorter recovery times. Recurrency in anterior and posterior compartment POP showed a difference in the two groups which, although not statistically significant, need to be evaluated in the long-term Type C/D pre C/D post p AS -1,9 -7,4 <0.001 LS -1,52 -7,36 <0.001 Total -1,7 -7,38 <0.001 © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e1035-e1036 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Manuel Di Biase More articles by this author Luigi Mearini More articles by this author Alessandro Zucchi More articles by this author Michele Del Zingaro More articles by this author Amelia Pietropaolo More articles by this author Eleonora Salvini More articles by this author Antonella Giannantoni More articles by this author Elisabetta Costantini More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...