Introduction and hypothesisThe objective was to evaluate the functional outcome after laparoscopic sacrocolpopexy versus open sacrocolpopexy in women with vault prolapse.MethodsA 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).ResultsBetween 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.ConclusionOur 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.

Introduction. Sacrocolpopexy is a generally applied treatment for vault prolapse which can be performed laparoscopically or by open laparotomy. Methods. Between October 2007 and December 2012, we performed a multicenter prospective cohort study in 2 university and 4 teaching hospitals in the Netherlands. We included patients with symptomatic posthysterectomy vaginal vault prolapse requiring surgical treatment, who either had abdominal or laparoscopic sacrocolpopexy. We studied surgery related morbidity, which was divided in pre-, peri-, and postoperative characteristics. Results. We studied 85 patients, of whom 42 had open abdominal and 43 laparoscopic sacrocolpopexy. In the laparoscopic sacrocolpopexy group, estimated blood loss was significantly less compared to the abdominal group: 192 mL (±126) versus 77 mL (±182), respectively (P ≤ .001). Furthermore, hospital stay was significantly shorter in the laparoscopic group (4.2 days) as compared to the abdominal group (2.4 days) (P ≤ .001). The overall complication rate was not significantly different (P = .121). However there was a significant difference in favor of the laparoscopic group in peri- and postoperative complications requiring complementary (conservative) treatment and/or extended admittance (RR 0.24 (95%-CI 0.07–0.80), P = .009). Conclusion. Laparoscopic sacrocolpopexy reduces blood loss and hospital stay as compared to abdominal sacrocolpopexy and generates less procedure related morbidity.

Objective To investigate whether laparoscopic sacrohysteropexy (LSH) is non‐inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse. Design Multicentre randomised controlled, non‐blinded non‐inferiority trial. Setting Five non‐university teaching hospitals in the Netherlands, one university hospital in Belgium. Population 126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery. Methods Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%. Main outcome measures Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP‐Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life. Results Laparoscopic sacrohysteropexy was non‐inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference −1.7%, 95% CI: −7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP. Conclusion Laparoscopic sacrohysteropexy was non‐inferior to SSHP for surgical failure of the apical compartment at 12 months’ follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent. Tweetable abstract Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short‐term outcomes.

BackgroundHysterectomy 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.MethodsWe 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.DiscussionThe 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 registrationNetherlands Trial Register (NTR): NTR3977; Registered 28 April 2013.

Introduction and hypothesis The objective of this study was to evaluate long-term outcomes of laparoscopic sacrocolpopexy (LSC) versus abdominal sacrocolpopexy (ASC) for vaginal vault prolapse (VVP). Methods Long-term follow-up of a multicenter randomized controlled trial (SALTO trial). A total of 74 women were randomly assigned to LSC ( n =37) or ASC ( n =37). Primary outcome was disease-specific quality of life, measured with validated questionnaires. Secondary outcomes included anatomical outcome, composite outcome of success, complications, and retreatment. Results We analyzed 22 patients in the LSC group and 19 patients in the ASC group for long-term follow-up, with a median follow-up of 109 months (9.1 years). Disease-specific quality of life did not differ after long-term follow-up with median scores of 0.0 (LSC: IQR 0–17; ASC: IQR 0–0) on the “genital prolapse” domain of the Urogenital Distress Inventory in both groups ( p = 0.175). Anatomical outcomes were the same for both groups on all points of the POP-Q. The composite outcome of success for the apical compartment is 78.6% ( n = 11) in the LSC group and 84.6% ( n = 11) in the ASC group ( p = 0.686). Mesh exposures occurred in 2 patients (12.5%) in the LSC group and 1 patient (7.7%) in the ASC group. There were 5 surgical reinterventions in both groups (LSC: 22.7%; ASC: 26.3%, p = 0.729). Conclusions At long-term follow-up no substantial differences in quality of life, anatomical results, complications, or reinterventions between LSC and ASC were observed. Therefore, the laparoscopic approach is preferable, considering the short-term advantages. Trial registration Dutch Trial Register NTR6330, 18 January 2017, https://www.trialregister.nl/trial/5964