Laparoscopic sacrocolpopexy versus vaginal sacrospinous fixation for vaginal vault prolapse: a randomised controlled trial and prospective cohort (SALTO‐2 trial) (original) (raw)
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BMC Women's Health
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, postoperative 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.
Asian Journal of Medical Sciences
Background: Post hysterectomy vault prolapse is a progressive herniation of the vaginal vault through the urogenital diaphragm and commonly leads to per vaginal bulge. Surgically, vault prolapse is corrected by sacrocolpopexy which can be done both as an open abdominal surgery and as a laparoscopic repair. Aims and Objectives: This study was performed to compare the therapeutic efficacies of laparoscopic and abdominal sacrocolpopexy. Materials and Methods: This study includes 50 cases of vault prolapsed who underwent hysterectomy previously, admitted in our institution and operated during January 2021–June 2022 for a period of 18 months with both open abdominal and laparoscopic sacrocolpopexy. We compared the basic characteristics, duration of surgery, post-operative stay, post-operative complications, and patient satisfaction between open and laparoscopic groups. Results: No significant difference was observed between the characteristics of the patients in the abdominal-approach gr...
Laparosopic sacrocolpopexy in the management of vaginal vault prolapse
Gynaecological Endoscopy, 1996
There are many procedures described for the treatment of vaginal vault prolapse. This paper describes the use of minimal access surgical techniques, in the form of laparoscopic sacrocolpopexy, for the treatment of this condition. The outcomes for the first 29 women to have undergone this procedure are described. Of the operations, 26 were completed without any intra-operative problems. On two occasions the bladder was perforated during the procedure, and in one case the inferior epigastric artery was injured. One patient had a urinary tract infection postoperatively. The remaining patients had uneventful postoperative courses. Most patients were discharged home on the 2nd postoperative day. All patients were reviewed at 2 weeks and at 6 weeks, and 28 have been reviewed at 3 months and at 6 months, and 14 for greater than 6 months, following surgery. All patients have been able to return to their normal lifestyle very rapidly and there were no reports of dyspareunia. There were eight cases of rectocoele at the 6-month review, and one patient had a recurrence of vault prolapse. Four patients have required a further surgical procedure, namely posterior repair. All except one patient had good support of the vaginal vault.
Sacrocolpopexy for posthysterectomy vaginal vault prolapse: long-term follow-up
International Urogynecology Journal, 2016
Introduction and hypothesis Abdominal sacrocolpopexy (ASC) is considered the gold standard for vaginal vault prolapse (VVP) repair. Our aim was to evaluate the long-term durability of its anatomic and functional results. Methods This was a prospective series of women undergoing ASC for symptomatic VVP stage III or IV according to the Pelvic Organ Prolapse Quantification (POP-Q) system. All patients were followed up every 3 months for the first postoperative year and then annually for anatomical and functional outcomes and complications. Only patients with at least 48 months of follow-up were included in this report. Anatomic success was defined as postoperative prolapse stage 0 or I. Statistical analysis was performed using the nonparametric Mann-Whitney U test for the analysis of continuous variables and the McNemar and χ 2 test for categorical data. Results Sixty-seven women were followed up for a median of 60 months (range 48-144). Anatomical success was 100 % for apical prolapse and 94 and 91 % for anterior and posterior compartments, respectively. There were only four (6 %) and six (9 %) cases of stage II persistence or recurrence for the anterior and posterior compartments, respectively, which did not require reoperation. There was no vault prolapse recurrence. Voiding and storage urinary and sexual symptoms were significantly improved. Anorectal dysfunction symptoms persisted in 40.6 % of patients with these symptoms preoperatively and developed de novo in 22.8 % of patients without them preoperatively. Three mesh exposures were noted. Sixtythree patients (94 %) were extremely or very much improved with sacrocolpopexy according to the Patient Global Impression-Improvement scale. Conclusions Our data confirm the long-term durability of vaginal vault prolapse repair with ASC.
Introduction Pelvic organ prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant negative influence on quality of life [1]. Some degree of prolapse is common in most parous women, but treatment is required only for the symptomatic patients [2]. Surgery for prolapse is one of the most common operations Performed in gynecology. In women, the lifetime risk of needing surgery for prolapse by the age of 80 is around 11%. It is interesting to note that 25% of these operations are performed for recurrent prolapse, suggesting that success rates for initial operations are poor [3]. The ideal procedure for vaginal apical support has yet to be determined. The past decade has seen several innovations in the treatment of prolapse due to greater understanding of pelvic anatomy and pathophysiology [2]. Abdominal sacral colpopexy is the gold standard abdominal procedure used for apical prolapse. Success rates range from 78% to 100%. This is prob...
International Urogynecology Journal
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 Bgenital 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.
The World Clinics Journal of Medical Sciences, 2017
he surgical repair of apical pelvic organ prolapse (POP) includes vaginal and abdominal approaches. 1 The vaginal approaches are lessmorbid than abdominal approaches.However, abdominal approaches provides lower recurrence rates and less dysparenuia than vaginal approaches. 2 Today, sacrocolpopexy is the gold standard procedure for apical POP repair. 1,2 The procedure that can be performed by abdominally (ASC), or minimally invasively (MISC), provides excellent anatomical and functional outcomes. 2 Since vaginal vault prolapses occured more rarely, the number of studies including MISCs are rare. 3 Herein we report our experience with abdominal and minimally invasive approaches of the sacrocolpopexy. In addition, we present the demographic, peri-and postoperative outcomes of abdominal and minimally invasive approaches. MATERIAL AND METHODS SUBJECTS A total of 41 consecutive women who were diagnosed with POP and underwent a sacrocolpopexy operation (21 ASC, 20 MISC) were included in
BioMed research international, 2018
Our aim was to study the efficacy of transvaginal bilateral sacrospinous fixation (TBSF) and its impact on quality of life (QoL) and sexual functions in women affected by second recurrences of vaginal vault prolapse (VVP). We performed a prospective observational study on 20 sexually active patients affected by second recurrence of VVP, previously treated with monolateral sacrospinous fixation. TBSF was performed in all the patients. They had been evaluated before the surgery and at 12-month follow-up through pelvic organ prolapse quantification (POP-Q) system, Short Form-36 (SF-36), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). At 12-month follow-up, 18 out of 20 (90%) patients were cured of their recurrent VVP. No major intra- and postoperative complications occurred. We found a significant improvement in 4/5 POP-Q landmarks (excluding total vaginal length), SF-36, and PISQ-12 scores. According to our data analysis, TBSF appears to be safe, effecti...
American Journal of Obstetrics and Gynecology, 2012
The objective of the study was to compare recurrence and complication rates for sacrospinous fixation (SSF) and prolene mesh techniques for the primary treatment of posthysterectomy vaginal vault prolapse. STUDY DESIGN: Patients undergoing surgery for vault prolapse were included in a multicenter, randomized, controlled study comparing SSF or total mesh (Prolift; Gynecare/Ethicon, Somerville, NJ). The examination included pelvic organ prolapse quantification, urodynamics, ultrasound, and quality-of-life (QoL) questionnaires before and 3 and 12 months after surgery. RESULTS: Of 168 randomized patients, 83 underwent SSF and 85 mesh repair. Prolapse recurrence after 12 months occurred in 39.4% of the SSF group and in 16.9% of the mesh group (P ϭ .003). The mesh exposure rate was 20.8%. No difference in QoL improvement as well as of de novo stress urinary incontinence and overactive bladder onset was found. CONCLUSION: Mesh exposure occurrence was balanced against a lower prolapse recurrence rate in the patients undergoing mesh surgery compared with those undergoing SSF.