Philip Rahmanou1, Natalia Price2, Simon R Jackson2. 1. Department of Urogynaecology, Women's Centre, Gloucester Royal Hospital NHS Foundation Trust, Great Western Road, Gloucester, GL1 3NN, UK. philip.rahmanou@glos.nhs.uk. 2. Department of Urogynaecology, Oxford University Hospitals, Oxford, UK.
Abstract
INTRODUCTION AND HYPOTHESIS: We have previously reported on laparoscopic hysteropexy for uterine prolapse. We now report a pilot randomized study comparing laparoscopic hysteropexy (LH) with vaginal hysterectomy (VH) for the surgical management of uterine prolapse. METHODS:Women with symptomatic uterine prolapse requiring surgery for uterine prolapse were recruited. The data were analyzed for those who had completed a 1-year follow-up. As this is a pilot randomized study, no power calculation was available. The main primary outcome measure was repeat apical prolapse. Secondary outcomes included operation data, complications, recovery time, functional and QoL outcomes, and anatomical outcomes. Wilcoxon signed rank and Mann-Whitney tests compared pre-operative with post-operative data and the difference between the two groups respectively. RESULTS:One hundred and thirty-two women were recruited. Of these, 101 were randomized. Eighty percent of the 31 women who dropped out preferred LH. One-year follow-up data were analyzed for 37 women in the LH and 35 women in the VH group. Time before return to normal activity was significantly shorter, estimated blood loss was significantly less, pain score 24 h post-operatively was significantly lower, and hospital stay was significantly shorter in the hysteropexy group compared with the vaginal hysterectomy group. Operation time was significantly longer in the hysteropexy group. Both procedures showed significant improvement in prolapse symptoms. Hysteropexy was associated with better apical support; point C and total vaginal length were significantly improved. More vaginal repairs were subsequently required post-hysteropexy. CONCLUSIONS:Laparoscopic hysteropexy is a safe surgical alternative to vaginal hysterectomy with a similar risk of repeat apical surgery at 1 year. Longer follow-up data from larger studies are required.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: We have previously reported on laparoscopic hysteropexy for uterine prolapse. We now report a pilot randomized study comparing laparoscopic hysteropexy (LH) with vaginal hysterectomy (VH) for the surgical management of uterine prolapse. METHODS:Women with symptomatic uterine prolapse requiring surgery for uterine prolapse were recruited. The data were analyzed for those who had completed a 1-year follow-up. As this is a pilot randomized study, no power calculation was available. The main primary outcome measure was repeat apical prolapse. Secondary outcomes included operation data, complications, recovery time, functional and QoL outcomes, and anatomical outcomes. Wilcoxon signed rank and Mann-Whitney tests compared pre-operative with post-operative data and the difference between the two groups respectively. RESULTS: One hundred and thirty-two women were recruited. Of these, 101 were randomized. Eighty percent of the 31 women who dropped out preferred LH. One-year follow-up data were analyzed for 37 women in the LH and 35 women in the VH group. Time before return to normal activity was significantly shorter, estimated blood loss was significantly less, pain score 24 h post-operatively was significantly lower, and hospital stay was significantly shorter in the hysteropexy group compared with the vaginal hysterectomy group. Operation time was significantly longer in the hysteropexy group. Both procedures showed significant improvement in prolapse symptoms. Hysteropexy was associated with better apical support; point C and total vaginal length were significantly improved. More vaginal repairs were subsequently required post-hysteropexy. CONCLUSIONS: Laparoscopic hysteropexy is a safe surgical alternative to vaginal hysterectomy with a similar risk of repeat apical surgery at 1 year. Longer follow-up data from larger studies are required.
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