Gynecologists' perspectives on surgical treatment for apical prolapse: a qualitative study.

INTRODUCTION AND HYPOTHESIS: Vaginal sacrospinous fixation (VSF) without mesh and sacrocolpopexy (SCP) with mesh are the most frequently performed surgical procedures for apical prolapse in the Netherlands. There is no long-term evidence suggesting the optimal technique, however. The aim was to identify which factors play a role in the choice between these surgical treatment options. METHODS: A qualitative study using semi-structured interviews amongst Dutch gynecologists was carried out. An inductive content analysis was performed with Atlas.ti. RESULTS: Ten interviews were analyzed. All gynecologists performed vaginal surgeries for apical prolapse, six gynecologists perform SCP themselves. Six gynecologists would perform VSF for a primary vaginal vault prolapse (VVP); three gynecologists preferred a SCP. All participants prefer a SCP for recurrent VVP. All participants have stated that multiple comorbidities could be a reason for choosing VSF, as this procedure is considered less invasive. Most participants choose a VSF in the case of older age (6 out of 10) or higher body mass index (7 out of 10). All treat primary uterine prolapse with vaginal, uterine-preserving surgery. CONCLUSIONS: Recurrent apical prolapse is the most important factor in advising patients which treatment they should undergo for VVP or uterine descent. Also, the patient's health status and the patient's own preference are important factors. Gynecologists who do not perform the SCP in their own clinic are more likely to perform a VSF and find more reasons not to advise a SCP. All participants prefer a vaginal surgery for a primary uterine prolapse.

Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO-2 trial).

OBJECTIVE: To determine whether laparoscopic sacrocolpopexy (LSC) or vaginal sacrospinous fixation (VSF) is the most optimal surgical treatment in patients with POP-Q stage ≥2 vaginal vault prolapse (VVP). DESIGN: Multicentre randomised controlled trial (RCT) and prospective cohort study alongside. SETTING: Seven non-university teaching hospitals and two university hospitals in the Netherlands. POPULATION: Patients with symptomatic post-hysterectomy vaginal vault prolapse, requiring surgical treatment. METHODS: Randomisation in a 1:1 ratio to LSC or VSF. Evaluation of prolapse was done using the pelvic organ prolapse quantification (POP-Q). All participants were asked to fill in various Dutch validated questionnaires 12 months postoperatively. MAIN OUTCOME MEASURES: Primary outcome was disease-specific quality of life. Secondary outcomes included composite outcome of success and anatomical failure. Furthermore, we examined peri-operative data, complications and sexual function. RESULTS: A total of 179 women, 64 women randomised and 115 women, participated in a prospective cohort. Disease-specific quality of life did not differ after 12 months between the LSC and VSF group in the RCT and the cohort (RCT: P = 0.887; cohort: P = 0.704). The composite outcomes of success for the apical compartment, in the RCT and cohort, were 89.3% and 90.3% in the LSC group and 86.2% and 87.8% in the VSF group, respectively (RCT: P = 0.810; cohort: P = 0.905). There were no differences in number of reinterventions and complications between both groups (reinterventions RCT: P = 0.934; cohort: P = 0.120; complications RCT: P = 0.395; cohort: P = 0.129). CONCLUSIONS: LSC and VSF are both effective treatments for vaginal vault prolapse, after a follow-up period of 12 months.

Laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy as treatment for uterine descent: comparison of long-term outcomes.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse (POP) is a frequent occurring health issue, especially concerning elderly women. The objective of this study is to examine the long-term outcomes of laparoscopic sacrohysteropexy (LSH) and vaginal sacrospinous hysteropexy (SSHP) for treatment of uterine prolapse. METHODS: A retrospective study of patients who underwent a LSH or SSHP. Validated questionnaires and an outpatient examination visit were used to investigate the effects of both surgical treatments. The primary outcome was the composite outcome of success for the apical compartment, defined as no recurrence of uterine prolapse (POP-Q measurement C ≤ 0), no subjective recurrence of POP, and/or not requiring therapy for recurrent prolapse. Secondary outcomes were peri- and postoperative data, anatomical failure, prolapse beyond hymen, subjective outcomes, and disease-specific quality of life. RESULTS: We included 105 patients, 53 in the LSH group and 52 in the SSHP group. The overall response rate of the questionnaires was 83% (n = 87) after a mean follow-up time of 4.5 years (54.2 months; 95% CI 44.8-64.2 months) in the LSH group and 2.5 years (30.1 months; 95% CI 29.3-31.5 months) in the SSHP group. There were no clinically relevant differences between the study groups in composite outcome of success (p = 0.073), anatomical failure of the apical compartment (p = 0.711), vaginal bulge symptoms for which patients consulted professionals (p = 0.126), and patient satisfaction (p = 0.741). The operative time was longer in the LSH group (117 min; interquartile range (IQR) 110-123) compared to the SSHP group (67 minutes; IQR 60-73) (p < 0.001). The duration of hospital stay was also longer in the LSH group (4 days) than in the SSHP group (3 days) (p = 0.006). CONCLUSIONS: LSH and SSHP seem to be equally effective after long-term follow-up in treating uterine prolapse in terms of objective and subjective recurrence.

Laparoscopic sacrocolpopexy versus abdominal sacrocolpopexy for vaginal vault prolapse: long-term follow-up of a randomized controlled trial.

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.

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

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.

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

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.

A Comparison of Complications between Open Abdominal Sacrocolpopexy and Laparoscopic Sacrocolpopexy for the Treatment of Vault Prolapse.

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.