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AUGS/IUGA Scientific Meeting 2019
Best Abstract Presentations / Late breaking Abstra ...
Best Abstract Presentations / Late breaking Abstracts - Best Clinical/Surgical Abstract & Best Basic Science Abstract
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of the five-year follow-up of the SAVE-U trial, which was a randomized clinical trial comparing the sacrospinous hysterectomy versus the vaginal hysterectomy with utero-sacral ligament suspension. I have nothing to disclose. First, the take-home message. I know that you will see many presentations in the coming days, but what I would like you to remember after my presentation is the following. After five-year follow-up, sacrospinous hysterectomy is more effective when compared to vaginal hysterectomy with utero-sacral ligament suspension and has a low risk of retreatment for recurrent prolapse. Therefore, we believe that women who require surgical correction of the uterine prolapse should be given the opportunity to choose uterus preservation and avoid hysterectomy. Uterus-preserving procedures are gaining popularity when compared to hysterectomy. In the Netherlands, sacrospinous hysterectomy is performed most often next to the vaginal hysterectomy. I'm just gonna adjust this a little bit. It's a little too close. Is that all right? Yeah. Studies show patients would prefer uterus preservation in case outcomes of these two operations were equal. So today I present to you the first long-term outcomes on comparison, which recently have been published in the BMJ. Oh, I'm sorry. In the initial trial, which was conducted from 2009 to 2012, 208 women were randomly assigned to either sacrospinous hysterectomy or vaginal hysterectomy with utero-sacral ligament suspension. All women were healthy and had a uterine stage two prolapse or higher. A follow-up was performed annually in the four participating hospitals until five years after surgery. As a primary outcome, we used surgical failure, which was defined as a recurrent prolapse, stage two or higher of the uterus or vaginal folds in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse. Follow-up included POPQ measurements annually during the outpatient visit and before every patient's visit, six different questionnaires. Secondarily, we looked at overall anatomical failure, which was defined as a stage two prolapse in any compartment. We looked at composite outcome of success, which was defined as no prolapse beyond the hymen, no bothersome bulge symptoms, and no repeat surgery or pass-through use for recurrent prolapse. We looked at functional outcome, quality of life, repeat surgery, and sexual functioning. All outcomes were analyzed by the intention to treat principal and surgical failure and the composite outcome of success were also analyzed by per protocol. Primarily, we performed a last observation carried forward analysis for missing data. And as a second strategy, we performed a survival analysis using a Kaplan-Meyer approach to estimate a cumulative incidence at five years of follow-up. For this extended trial, a total of 204 patients were available for follow-up analysis. POPQ scores of 81% of all the women were available at five years of follow-up. The baseline characteristics did not differ significantly between groups. And in both groups, two thirds of all the included patients had a stage two uterine prolapse before surgery. After 12 months, treatment with sacrospinous hystereopoxy was found to be non-inferior to vaginal hysterectomy with suspension of the utero-sacral ligament for surgical failure of the apical compartment. It was found zero times in sacrospinous hystereopoxy group versus four times after vaginal hysterectomy. This is a difference of 3.9%. Secondarily, no notable differences were found on secondary outcomes between the interventions. Onto the five-year follow-up. Surgical failure of the apical compartment occurred significantly less after sacrospinous hystereopoxy and was found in only one women compared to eight women in the vaginal hysterectomy group. So the difference that I showed you before from 3.9% has increased to 6.7%. Overall, anatomical failure did not differ significantly between groups. If we look at a composite outcome of success, we can see that it was found significantly more after sacrospinous hystereopoxy where it was found in 89 women compared to 77 women after vaginal hysterectomy. Looking at the protocol analysis, we can see that it is not statistically significant, but still the results are in favor of sacrospinous hystereopoxy. Repeat surgery at five-year follow-up did not differ significantly between groups. Repeat surgery for recurrent prolapse was found three times after sacrospinous hystereopoxy versus seven times after vaginal hysterectomy. And for the apical prolapse, it was found once after sacrospinous hystereopoxy versus four times after vaginal hysterectomy. And all patients who got a retreatment received a sacrocopopexy. Surgery for non-prolapse conditions did not differ significantly between groups. Functional outcome and quality of life did not differ significantly between groups. And among the patients who completed the PISQ before surgery and five years after surgery, there was a significant improvement in scores in both groups, but there was no statistically significant difference between the groups. In the survival analysis, no statistically significant differences were found. Onto the conclusions. So this was the first randomized trial comparing the sacrospinous hystereopoxy versus the vaginal hysterectomy with a follow-up of five year with relevant outcome measures and a large group of women who completed follow-up. Our results show that sacrospinous hystereopoxy is an effective and safe option in the surgical treatment of uterine prolapse and has a low risk of retreatment when compared to vaginal hysterectomy. Therefore, we believe that women who require surgical correction of the uterine prolapse should be given the opportunity to choose uterus preservation and avoid hysterectomy. More randomized trials comparing other uterus preserving procedures are needed to compare efficacy and safety among the different procedures. And in the Netherlands, two large trials have started comparing the sacrospinous hystereopoxy to either the modified Manchester and the laparoscopic hystereopoxy. And these are the SAM trial and the LAVA trial. Thank you for your attention. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. 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Video Summary
In a five-year follow-up of the SAVE-U trial, which compared sacrospinous hysterectomy to vaginal hysterectomy with utero-sacral ligament suspension, researchers found that sacrospinous hysterectomy was more effective and had a lower risk of retreatment for recurrent prolapse. The study included 208 women with uterine stage two prolapse or higher, who were randomly assigned to either sacrospinous hysterectomy or vaginal hysterectomy with utero-sacral ligament suspension. The primary outcome measure was surgical failure, defined as recurrent prolapse combined with bothersome bulge symptoms or repeat surgery. After 12 months, sacrospinous hystereopoxy was found to be non-inferior to vaginal hysterectomy for surgical failure. In the five-year follow-up, surgical failure of the apical compartment occurred significantly less frequently after sacrospinous hysterectomy, with only one woman experiencing it compared to eight women in the vaginal hysterectomy group. Overall anatomical failure did not significantly differ between groups. However, a composite outcome of success was found significantly more often after sacrospinous hystereopoxy. Repeat surgery for recurrent prolapse was also less frequent after sacrospinous hystereopoxy. Functional outcome, quality of life, and sexual functioning did not differ significantly between the two procedures. The study concludes that sacrospinous hystereopoxy is an effective and safe option in the surgical treatment of uterine prolapse and offers women the opportunity to choose uterus preservation and avoid hysterectomy. Further studies comparing other uterus-preserving procedures are needed.
Asset Caption
Sascha FM Schulten, Kathleen A. Connell, MD, Olivia H. Chang, MD, MPH
Keywords
SAVE-U trial
sacrospinous hysterectomy
vaginal hysterectomy
utero-sacral ligament suspension
recurrent prolapse
surgical failure
repeat surgery
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