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Int Urogynecol J. 2017 Oct;28(10):1469-1479. doi: 10.1007/s00192-017-3296-5. Epub 2017 Apr 17.

Laparoscopic sacrocolpopexy compared with open abdominal sacrocolpopexy for vault prolapse repair: a randomised controlled trial.

Author information

1
Department of Gynaecology and Obstetrics, Máxima Medical Centre, De Run 4600, 5500 MB, Veldhoven, The Netherlands. anne_lotte_coolen@hotmail.com.
2
Department of Gynaecology and Obstetrics, University of Maastricht, Minderbroedersberg 4-6, 6211 LK, Maastricht, The Netherlands. anne_lotte_coolen@hotmail.com.
3
Department of Gynaecology and Obstetrics, Máxima Medical Centre, De Run 4600, 5500 MB, Veldhoven, The Netherlands.
4
Department of Gynaecology and Obstetrics, The Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, 5000, Adelaide, SA, Australia.
5
Department of Gynaecology and Obstetrics, The South Australian Health and Medical Research Institute, Adelaide, Australia.
6
Department of Gynaecology and Obstetrics, Isala Klinieken, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
7
Department of Gynaecology and Obstetrics, Academic Medical Centre Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
8
Department of Gynaecology and Obstetrics, University of Maastricht, Minderbroedersberg 4-6, 6211 LK, Maastricht, The Netherlands.

Abstract

INTRODUCTION AND HYPOTHESIS:

The objective was to evaluate the functional outcome after laparoscopic sacrocolpopexy versus open sacrocolpopexy in women with vault prolapse.

METHODS:

A multicentre randomised controlled trial was carried out at four teaching and two university hospitals in the Netherlands in women with symptomatic vault prolapse requiring surgical treatment. Participants were randomised for laparoscopic or open sacrocolpopexy. Primary outcome was disease-specific quality of life measured using the Urinary Distress Inventory (UDI) questionnaire at 12 months' follow-up. Secondary outcomes included anatomical outcome and perioperative data. We needed 74 participants to show a difference of 10 points on the prolapse domain of the UDI 12 months after surgery (power of 80%, α error 0.05).

RESULTS:

Between 2007 and 2012, a total of 74 women were randomised. Follow-up after 12 months showed no significant differences in domain scores of the UDI between the two groups. After 12 months, both groups reported a UDI score of 0.0 (IQR: 0-0) for the domain "genital prolapse", which was the primary outcome. There were no significant differences between the two groups (p = 0.93). The number of severe complications was 4 in the laparoscopic group versus 7 in the open abdominal group (RR 0.57; 95% CI 0.50-2.27). There was less blood loss and a shorter hospital stay after laparoscopy; 2 (IQR 2-3) versus 4 (IQR 3-5) days, which was statistically different. There was no significant difference in anatomical outcome at 12 months.

CONCLUSION:

Our trial provides evidence to support a laparoscopic approach when performing sacrocolpopexy, as there was less blood loss and hospital stay was shorter, whereas functional and anatomical outcome were not statistically different.

KEYWORDS:

Pelvic organ prolapse; Sacral colpopexy; Sacrocolpopexy; Vault prolapse

PMID:
28417153
PMCID:
PMC5606943
DOI:
10.1007/s00192-017-3296-5
[Indexed for MEDLINE]
Free PMC Article

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