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BMC Womens Health. 2017 Jul 26;17(1):52. doi: 10.1186/s12905-017-0402-2.

Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse, a randomized controlled trial: SALTO-2 trial, study protocol.

Author information

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

Abstract

BACKGROUND:

Hysterectomy is one of the most performed surgical procedures during lifetime. Almost 10 % of women who have had a hysterectomy because of prolapse symptoms, will visit a gynaecologist for a surgical correction of a vaginal vault prolapse thereafter. Vaginal vault prolapse can be corrected by many different surgical procedures. A Cochrane review comparing abdominal sacrocolpopexy to vaginal sacrospinous fixation considered the open abdominal procedure as the treatment of first choice for prolapse of the vaginal vault, although operation time and hospital stay is longer. Literature also shows that hospital stay and blood loss are less after a laparoscopic sacrocolpopexy compared to the abdominal technique. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Prospective trials comparing vaginal sacrospinous fixation and laparoscopic sacrocolpopexy are lacking. The aim of this randomized trial is to compare the disease specific quality of life of the vaginal sacrospinous fixation and laparoscopic sacrocolpopexy as the treatment of vaginal vault prolapse.

METHODS:

We will perform a multicentre prospective randomized controlled trial. Women with a post-hysterectomy symptomatic, POP-Q stage ≥2, vaginal vault prolapse will be included. Participants will be randomized to the vaginal sacrospinous fixation group or the laparoscopic sacrocolpopexy group. Primary outcome is disease specific quality of life at 12 months follow-up. Secondary outcome will be the effect of the surgical treatment on prolapse related symptoms, sexual functioning, procedure related morbidity, hospital stay, post-operative recovery, anatomical results using the POP-Q classification after one and 5 years follow-up, type and number of re-interventions, costs and cost-effectiveness. Analysis will be performed according to the intention to treat principle and not as a per protocol analysis. With a power of 90% and a level of 0.05, the calculated sample size necessary is 96 patients. Taking into account 10% attrition, a number of 106 patients (53 in each arm) will be included.

DISCUSSION:

The SALTO-2 trial is a randomized controlled multicentre trial to evaluate whether the laparoscopic sacrocolpopexy or vaginal sacrospinous fixation is the first-choice surgical treatment in patients with a stage ≥2 vault prolapse.

TRIAL REGISTRATION:

Netherlands Trial Register (NTR): NTR3977 ; Registered 28 April 2013.

KEYWORDS:

Laparoscopic sacral colpopexy; Laparoscopic sacrocolpopexy; Pelvic organ prolapse; Vaginal sacrospinous ligament fixation; Vaginal sacrospinous suspension; Vault prolapse

PMID:
28747206
PMCID:
PMC5530566
DOI:
10.1186/s12905-017-0402-2
[Indexed for MEDLINE]
Free PMC Article

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