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.

Practice pattern variation: treatment of pelvic organ prolapse in The Netherlands.

INTRODUCTION AND HYPOTHESIS: Great variety in clinical management of pelvic organ prolapse (POP) has been described over the last years. Practice pattern variation (PPV) reflects differences in care that cannot be explained by the underlying condition. We aim to explore whether PPV in management of POP in The Netherlands has changed between 2011 and 2017. METHODS: We conducted a multicenter cohort study, using prospective routinely collected benchmark data from LOGEX, a healthcare analytics company (Amsterdam, The Netherlands). Data of patients with a diagnosis POP from 50 hospitals (16 teaching and 34 non-teaching hospitals) were collected for the years 2011 and 2017. All treatments were categorized into three groups: conservative treatment, uterus-preserving or uterus-removing surgery. Using meta-analysis, we evaluated whether the proportions of conducted treatments changed over time and estimated the between-center variation (Cochran's Q), reflecting the PPV in 2011 and 2017. This variation was analyzed using F-tests. RESULTS: Compared to 2011, referral for POP in 2017 decreased by 16.2% (-4505 patients), and the percentage of hysterectomies decreased by 33.6% (p < 0.0001). The PPV of POP surgery decreased significantly by 47.2% (p = 0.0137) and of hysterectomies by 41.5% (p = 0.0316). CONCLUSIONS: We found a decline in PPV for POP surgery between 2011 and 2017. Furthermore, the number of surgical interventions decreased, which was mostly due to a decline of hysterectomies. This indicates a shift toward more conservative therapy and uterus preservation. A further reduction of PPV would be beneficial for the quality of health care.

Dynamic magnetic resonance imaging to quantify pelvic organ mobility after treatment for uterine descent: differences between surgical procedures.

INTRODUCTION AND HYPOTHESIS: Pelvic organ mobility is defined as the displacement of pelvic organs between rest and maximal straining. We hypothesized that pelvic organ mobility after vaginal sacrospinous hysteropexy (SSHP) might be increased compared with other surgeries for uterine descent, which may contribute to the high occurrence of postoperative cystocele after this surgery. Pelvic organ mobility and the vaginal axes after SSHP are compared with other surgical procedures for uterine descent: vaginal hysterectomy with uterosacral suspension (VH) and laparoscopic sacrohysteropexy (LSH). METHODS: In this prospective pilot study, 15 women were included (5 for each procedure). Six months postoperatively, POP-Q examination and dynamic MRI were performed and questionnaires were filled out regarding prolapse complaints. Pelvic organ mobility on MRI was defined as vertical displacement of pelvic organs at rest and maximal straining. The displacements and angles were measured using an image registration method. Furthermore, the angle of displacement of cervix/vaginal vault and vaginal axes were assessed. RESULTS: No anatomical recurrences of pelvic organ prolapse were found. No difference in pelvic organ mobility was demonstrated. After VH, a more posterior position of the upper vagina was found compared with SSHP and LSH. CONCLUSIONS: Based on these data, the higher recurrence risk in the anterior compartment after SSHP cannot be explained. Larger sample sizes, studying women with recurrence or de novo cystocele after SSHP or using an upright MRI scanner would be of interest to further assess the relationship between pelvic organ mobility and the occurrence of anterior vaginal wall prolapse.

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.

Practice pattern variation in surgical management of pelvic organ prolapse and urinary incontinence in The Netherlands.

INTRODUCTION: Practice pattern variation (PPV) is the difference in care that cannot be explained by the underlying medical condition. The aim of this study was to describe PPV among Dutch gynecologists regarding treatment of pelvic organ prolapse (POP) and urinary incontinence (UI). MATERIALS AND METHODS: PPV was calculated from data of healthcare declaration codes of 2010. Data were provided by Vektis and Kiwa Carity. PPV for POP and UI in general was calculated per hospital and per region. Furthermore, PPV for transvaginal mesh and surgical treatment of uterine descent was assessed. RESULTS: PPV of surgical treatment for POP and UI in general was assessed for 91 hospitals. PPV for surgical treatment of uterine descent and transvaginal mesh placement was calculated for 88 hospitals. A high PPV per hospital and per region was found. In some hospitals, a hysterectomy was performed in all cases of uterovaginal prolapse, while in other hospitals, uterus-preserving techniques were mostly performed. A high PPV of transvaginal mesh placement was observed. CONCLUSION: In the small country of The Netherlands, we found a high PPV in surgical management of POP and UI with respect to the choice for surgical treatment and the type of surgery. This finding might be due to the absence of clearly defined guidelines. Studies with respect to conservative versus surgical treatment and the type of surgery are of need to establish evidence-based guidelines.

Variation in the practice of laparoscopic sacrohysteropexy and laparoscopic sacrocolpopexy for the treatment of pelvic organ prolapse: a Dutch survey.

INTRODUCTION AND HYPOTHESIS: Laparoscopic techniques for pelvic organ prolapse surgery using mesh are gaining interest. A standard approach or published guideline for the laparoscopic sacrohysteropexy (LSH) or laparoscopic sacrocolpopexy (LSC) is lacking. The purpose of this study is to assess the variation between Dutch gynecologists in executing LSH and LSC. METHODS: A questionnaire was developed to evaluate the technique of LSH and LSC. All members of the Dutch Society for Gynecological Endoscopy and Minimally Invasive Surgery and the Dutch Society for Urogynecology were invited by email to participate in a web-based survey. RESULTS: With 357 respondents, the response rate was 71%. Of the respondents, a total of 49 gynecologists (13.7%) perform LSH and/or LSC. Gynecologists who perform both procedures use the same surgical technique for LSH and LSC. There are variations among gynecologists on several key points such as the level of dissection along the anterior and posterior walls of the vagina, the type of mesh used, the type of sutures used, the tension of the implanted mesh and reperitonealization of the mesh. CONCLUSIONS: There is a high practice variation in LSH and LSC performed by a selected group of Dutch gynecologists. Different methods have been described in the literature and there is no consensus on how to perform these procedures. A well-designed prospective study or randomized controlled trial with regard to the specific parts of these procedures is needed to provide evidence for the best surgical technique. The outcomes of these studies will help to establish evidence-based guidelines.

Dutch women's attitudes towards hysterectomy and uterus preservation in surgical treatment of pelvic organ prolapse.

OBJECTIVE: To investigate Dutch women's attitudes and preferences towards hysterectomy or uterus preservation in surgical treatment of pelvic organ prolapse. STUDY DESIGN: Women's attitude was assessed by a structured questionnaire in one university hospital and one non-university teaching hospital in the Netherlands. Between December 2013 and November 2014, 102 women referred with prolapse complaints, without previous prolapse surgery, responded to the questionnaire received by mail prior to gynaecological consultation. Main outcome was the preference for uterus preserving surgery versus hysterectomy. Furthermore we studied the impact of uterus preservation and hysterectomy on body image and sexual function and the importance of treatment success, risk of urinary incontinence after surgery, complication risk, recovery time, length of hospital stay, costs and the risk of developing endometrial cancer. RESULTS: Assuming that functional and anatomical outcomes after hysterectomy and uterus preserving surgery were equal, more women expressed preference for uterus preservation (43%, 44 out of 102 women) compared to hysterectomy (27%, 27 out of 102 women). The majority of women expected a similar improvement in sexuality and body image after the two treatment modalities. Treatment success, risk for urinary incontinence after surgery and complication risk were the most important factors. Taken the future risk of endometrial cancer into account, 18% of the women preferred hysterectomy because of this risk. CONCLUSIONS: This study demonstrated that women referred with prolapse complaints have a preference for uterus preservation in case outcomes after both interventions are expected to be equal. The majority of women expected that body image and sexual function would equally improve after both interventions.

[Lichen sclerosus and Turner syndrome]. / Lichen sclerosus en het syndroom van Turner.

Lichen sclerosus was diagnosed at a young age (19, 22 and 37 years) in three women with Turner syndrome. The oldest of these patients had probably suffered from this disorder for over 20 years. The relatively young age of these three patients is remarkable. This observation also suggests an increased frequency of lichen sclerosus among women with Turner syndrome. Immunological and hormonal factors might explain this association. Early detection of lichen sclerosus is important, as malignant transformation into carcinoma of the vulva may occur. It is advisable to perform regular gynaecological examination as part of the recommended periodic screening of adult women with Turner syndrome.