Urogenital cultures and preterm birth in women with cervical cerclage: a single center retrospective cohort study.

BACKGROUND: The leading hypothesis of the pathogenesis of cervical insufficiency suggests a role of cervical inflammation. Urogenital tract infections could play a causative role in this process. To test this hypothesis in women with a cervical cerclage, we aimed to retrospectively examine the relationship between gestational age (GA) at delivery and positive urogenital cultures. METHODS: This single center retrospective study reviewed the records of all women with a singleton pregnancy that underwent cervical cerclage (n = 203) between 2010 and 2020 at the University Hospital of Leuven, Belgium. Transvaginal cerclages were categorized as history indicated (TVC I, n = 94), ultrasound indicated (TVC II, n = 79) and clinically indicated (TVC III, n = 20). Additionally, ten women received transabdominal cerclage (TAC). Urogenital cultures (vaginal and urine) were taken before and after cerclage with 4-week intervals. Urogenital cultures were reported 'positive' if urine and/or vaginal cultures showed significant growth of a microorganism. Treatment decision depended on culture growth and clinical presentation. The primary aim was to evaluate the association between the urogenital culture results and the GA at delivery, for each of the cerclage groups. Secondarily, to investigate the effect of antibiotic treatment of positive cultures on GA at delivery. RESULTS: Positive pre-cerclage urogenital cultures were associated with lower GA at delivery in TVC III (positive culture 26w4d ± 40d vs. negative 29w6d ± 54d, p = 0.036). For TVC I, GA at delivery was longer when pre-cerclage urogenital cultures were positive (positive culture 38w0d ± 26d vs. negative 35w4d ± 42d, p = 0.035). Overall post-cerclage urogenital cultures status was not associated with a different GA at delivery. Treating patients with pre- or post-cerclage positive urogenital cultures did also not change GA at delivery. CONCLUSION: Positive urogenital cultures taken before clinically indicated cerclage intervention may be associated with lower GA at delivery. However, there seems to be no benefit of antibiotic treatment or routine urogenital cultures during follow-up of asymptomatic women after cerclage placement.

Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial.

OBJECTIVE: To assess whether CO2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM). DESIGN: Single-centre, sham-controlled, double-blind, randomised trial. SETTING: A tertiary centre in Belgium. POPULATION: Sixty women with moderate to severe GSM symptoms. METHODS: All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely. MAIN OUTCOME MEASURES: The primary outcome was the participant-reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short-term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit. RESULTS: The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (-23.60%; 95% CI -36.10% to -11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (-13.20%; 95% CI -22.70% to -3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months. CONCLUSIONS: In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.

Safety and medium-term outcome of redo laparoscopic sacrocolpopexy: a matched case-control study.

INTRODUCTION AND HYPOTHESIS: In the case of recurrent apical prolapse following laparoscopic sacrocolpopexy (LSCP), one may consider a "redo" procedure. We hypothesized that redo LSCP may carry an increased complication risk and less favorable outcomes when compared with primary procedures. METHODS: This is a single-center, matched case-control (1:4) study, comparing all 39 women who had a redo LSCP and 156 women who had a primary LSCP for symptomatic apical prolapse between 2002 and 2020 with a minimum follow-up of 12 months. Matching was based on proximity to the operation date. The primary outcome was the occurrence of intraoperative and early postoperative complications within 3 months. Secondary outcomes included subjective (Patient Global Impression of Change [PGIC] ≥4) and objective (Pelvic Organ Prolapse Quantification [POP-Q] stage <2) success rates, surgical variables, graft-related complications and reinterventions. RESULTS: There was no difference in the rate of intraoperative and early postoperative complications (redo: 21.1% vs control: 29.8%, OR: 0.63, 95% CI 0.27-1.48). The conversion rate was higher in redo patients (redo: 10.3% vs control: 0.6, OR: 17.71, 95% CI 1.92-163.39). Early postoperative complications were comparable: they were mainly infectious and managed by antibiotics. At a comparable follow-up (redo: 81 months (IQR: 54) vs control: 71.5 months (IQR: 42); p=0.37), there were no differences in graft-related complications (redo: 17.9% vs control: 9.6%, p=0.14) and reinterventions for complications (redo: 12.8% vs control: 5.1%, p=0.14) or prolapse (redo: 15.4% vs control: 8.3%, p=0.18). Subjective (redo: 88.5% vs control: 80.2%, p=0.41) and objective (redo: 31.8% vs control: 24.7%, p=0.50) success rates were also comparable. CONCLUSIONS: In our experience, redo LSCP is as safe and effective as a primary LSCP, but there is a higher risk of conversion.

Pregnancy, labour and delivery as risk factors for pelvic organ prolapse: a systematic review.

INTRODUCTION: Pregnancy and childbirth are considered risk factors for pelvic organ prolapse (POP). The long latency between obstetric events and morbidity hinders the establishment of cause-effect relationships. Recently, intermediate outcomes such as organ descent and levator avulsion (LA) have been identified. We aimed to assess the effect of obstetric events on symptoms and signs of POP and on LA. METHODS: We systematically reviewed the literature by searching PubMed/MEDLINE, Embase and Cochrane Library. We included studies in women examining associations between obstetric events and symptoms and signs of POP and LA, assessed through questionnaires, clinical examination and pelvic floor imaging. Two reviewers evaluated the studies for eligibility and for methodological quality/susceptibility to bias. We extracted study results and clustered them by outcome: symptoms of POP (sPOP), clinical findings of POP (cPOP) and LA. When appropriate, we performed a random-effect meta-analysis and reported the summary odds ratios (OR) with 95% confidence intervals. Heterogeneity across studies was assessed using the I2 statistic. RESULTS: The first vaginal delivery was a risk factor for POP as measured by sPOP (OR: 2.65 [1.81-3.88]), cPOP (OR: 4.85 [2.15-10.94]) and in association with LA (OR: 41.6 [4.13- 419.41]). Forceps delivery was a risk factor for POP as measured by sPOP (OR: 2.51 [1.34-4.69]), cPOP (OR: 1.68 [1.21-2.34]) and in association with LA (OR: 5.92 [3.75-9.34]). Birth exclusively by caesarean was protective for sPOP (OR: 0.38 [0.29-0.51]) and for cPOP (OR: 0.29 [0.20-0.41]) and it did not confer any additional risk compared to nulliparity. CONCLUSIONS: This review confirms a strong aetiological link between vaginal birth and POP, with the first vaginal and forceps delivery being the main determinants.

Approaches for hysterectomy and implementation of robot-assisted surgery in benign gynaecological disease: A cost analysis study in a large university hospital.

BACKGROUND: As a minimally invasive technique, robot-assisted hysterectomy (RAH) offers surgical advantages and significant reduction in morbidity compared to open surgery. Despite the increasing use of RAH in benign gynaecology, there is limited data on its cost-effectiveness, especially in a European context. Our goal is to assess the costs of the different hysterectomy approaches, to describe their clinical outcomes, and to evaluate the impact of introduction of RAH on the rates of different types of hysterectomy. METHODS: A retrospective single-centre cost-analysis was performed for patients undergoing a hysterectomy for benign indications. Abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), laparoscopically assisted vaginal hysterectomy (LAVH) and RAH were included. We considered the costs of operating room and hospital stay for the different hysterectomy techniques using the "Activity Centre-Care program model". We report on intra- and postoperative complications for the different approaches as well as their cost relationship. RESULTS: Between January 2014 and December 2021, 830 patients were operated; 67 underwent VH (8%), 108 LAVH (13%), 351 LH (42%), 148 RAH (18%) and 156 AH (19%). After the implementation and learning curve of a dedicated program for RAH in 2018, AH declined from 27.3% in 2014-2017, to 22.1% in 2018 and 6.9 % in 2019-2021. The reintervention rate was 3-4% for all surgical techniques. Pharmacological interventions and blood transfusions were performed after AH in 28%, and in 17-22% of the other approaches. AH had the highest hospital stay cost with an average of €2236.40. Mean cost of the hospital stay ranged from €1136.77-€1560.66 for minimally invasive techniques. The average total costs for RAH were €6528.10 compared to €4400.95 for AH. CONCLUSION: Implementation of RAH resulted in a substantial decrease of open surgery rate. However, RAH remains the most expensive technique in our cohort, mainly due to high material and depreciation costs. Therefore, RAH should not be considered for every patient, but for those who would otherwise need more invasive surgery, with higher risk of complications. Future prospective studies should focus on the societal costs and patient reported outcomes, in order to do cost-benefit analysis and further evaluate the exact value of RAH in the current healthcare setting.

High-fidelity, low-cost synthetic training model for fetoscopic spina bifida repair.

BACKGROUND: Fetoscopic spina bifida repair is increasingly being practiced, but limited skill acquisition poses a barrier to widespread adoption. Extensive training in relevant models, including both ex vivo and in vivo models may help. To address this, a synthetic training model that is affordable, realistic, and that allows skill analysis would be useful. OBJECTIVE: This study aimed to create a high-fidelity model for training in the essential neurosurgical steps of fetoscopic spina bifida repair using synthetic materials. In addition, we aimed to obtain a cheap and easily reproducible model. STUDY DESIGN: We developed a 3-layered, silicon-based model that resemble the anatomic layers of a typical myelomeningocele lesion. It allows for filling of the cyst with fluid and conducting a water tightness test after repair. A compliant silicon ball mimics the uterine cavity and is fixed to a solid 3-dimensional printed base. The fetal back with the lesion (single-use) is placed inside the uterine ball, which is reusable and repairable to allow for practicing port insertion and fixation multiple times. Following cannula insertion, the uterus is insufflated and a clinical fetoscopic or robotic or prototype instruments can be used. Three skilled endoscopic surgeons each did 6 simulated fetoscopic repairs using the surgical steps of an open repair. The primary outcome was surgical success, which was determined by water tightness of the repair, operation time <180 minutes and an Objective Structured Assessment of Technical Skills score of ≥18 of 25. Skill retention was measured using a competence cumulative sum analysis of a composite binary outcome of surgical success. Secondary outcomes were cost and fabrication time of the model. RESULTS: We made a model that can be used to simulate the neurosurgical steps of spina bifida repair, including anatomic details, port insertion, placode release and descent, undermining of skin and muscular layer, and endoscopic suturing. The model was made using reusable 3-dimensional printed molds and easily accessible materials. The 1-time startup cost was €211, and each single-use, simulated myelomeningocele lesion cost €9.5 in materials and 50 minutes of working time. Two skilled endoscopic surgeons performed 6 simulated, 3-port fetoscopic repairs, whereas a third used a Da Vinci surgical robot. Operation times decreased by more than 30% from the first to the last trial. Six experiments per surgeon did not show an obvious Objective Structured Assessment of Technical Skills score improvement. Competence cumulative sum analysis confirmed competency for each surgeon. CONCLUSION: This high-fidelity, low-cost spina bifida model allows simulated dissection and closure of a myelomeningocele lesion. VIDEO ABSTRACT.

Motion and viewing analysis during minimally invasive surgery for autostereoscopic visualization.

PURPOSE: Autostereoscopic 3D visualization (ASV) forms a potentially appealing alternative to stereoscopic 3D displays to help surgeons regain depth perception during minimally invasive surgery (MIS). However, the feasibility of using single-viewer ASV has not yet been demonstrated in a clinical context. The purpose of the study is to analyze the current surgical workflow and display usage and assess the potential for using ASV in MIS applications. Additionally, the study seeks to acquire a better understanding of key design requirements, such as the eye-tracking performance and the lenticular lens 3D workspace. METHODS: Two types of gynecologic interventions were investigated. A vision-based tracking system was developed, consisting of depth cameras mounted on the displays and ArUco markers placed on the hair caps of clinicians and the wall of the operating room. This allowed simultaneous tracking of the pose of operating staff and displays. RESULTS: Overall 20 surgeries were recorded, where 4 clinicians operated using 3 displays. Users were typically standing at a mean distance of 1900 mm in a range from to 1200 to 2300 mm from the display. Left-right motion was from - 600 to 658 mm. Clinicians stood on average 1000 mm from each other. The head roll angle was below 16[Formula: see text]. CONCLUSION: Surgeons were looking predominantly (99%) to the same display. Observations took place from fairly well-defined places and with sufficient potential to differentiate between clinicians, suggesting that single-viewer ASV would be feasible.

Long-term Data on Graft-Related Complications After Sacrocolpopexy With Lightweight Compared With Heavier-Weight Mesh.

OBJECTIVE: To estimate the long-term incidence and characteristics of graft-related complications, rate of reintervention for graft-related complications and prolapse, and subjective and anatomical outcomes after laparoscopic sacrocolpopexy with heavier-weight (more than 44 g/m2) compared with lightweight (28 g/m2) polypropylene mesh, the latter with resorbable poliglecaprone component. METHODS: We conducted a single-center study that compared two consecutive prospective cohorts of patients who were undergoing laparoscopic sacrocolpopexy for symptomatic stage 2 or greater cervical or vault prolapse, by using either heavier-weight polypropylene mesh or lightweight polypropylene mesh at a similar duration of follow-up. The primary outcome was the occurrence of graft-related complications and their nature. Secondary outcomes included reinterventions for graft-related complications, recurrent apical prolapse, a subjective outcome (PGIC [Patient Global Impression of Change] score 4 or higher), and an anatomical outcome (point C -1 cm or greater). RESULTS: We identified consecutive patients: 101 were implanted with heavier-weight polypropylene, and 238 were implanted with lightweight polypropylene; all were audited at comparable follow-up times (heavier-weight mesh: 97 months [interquartile range 16 months]; lightweight mesh: 92.5 months [interquartile range 58 months]). Graft-related complications were more frequent in patients with heavier-weight than lightweight mesh (22.8% [23/101] vs 7.3% [13/178]; hazard ratio [HR] 3.3, 95% CI 1.6-7.1), more frequently symptomatic (heavier-weight mesh: 16.8% [17/101] vs lightweight mesh: 2.8% [5/178]; HR 6.0, 95% CI 2.5-14.3), and more frequently lead to reintervention for graft-related complications (heavier-weight mesh: 18.8% [19/101] vs lightweight mesh: 2.1% [5/238]; HR 4.6, 95% CI 1.9-11.2). The vast majority of patients improved (PGIC score 4 or higher), without difference between groups (heavier-weight mesh: 71/84 [84.9%]; lightweight mesh: 154/178 [86.5%]; HR 0.8, 95% CI 0.6-1.1); neither was there a difference in anatomical failure rate (heavier-weight mesh: 1/60 [1.7%] vs lightweight mesh: 8/131 [6.1%]; HR 0.3, 95% CI 0.1-1.4). Reoperations for recurrent vault prolapse were scarce (0.0% in heavier-weight mesh, vs 0.4% in lightweight mesh). CONCLUSION: In two consecutive cohorts, the number of graft-related complications, symptomatic graft-related complications, and reinterventions for graft-related complications were higher in patients implanted with heavier-weight polypropylene than when lightweight polypropylene was used. There were no differences in subjective, objective outcomes, and reoperation rates for prolapse. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04378400. FUNDING: To assist in this audit, the University Hospitals Leuven received support from Ethicon Endosurgery.

Cervicosacropexy or vaginosacropexy for urinary incontinence and apical prolapse: A systematic review.

Several anatomic theories suggest that lax uterosacral ligaments may result in apical prolapse and urinary incontinence. Therefore, prolapse repair such as cervicosacropexy or vaginosacropexy, may resolve urinary incontinence. Shortcomings in current treatment options endorse further exploration of the potential benefit of a surgical alternative. This systematically review of the literature aimed to summarize the evidence on the efficacy and safety of cervicosacropexy and vaginosacropexy as alternative surgical treatment options for urge and/or mixed urinary incontinence and apical prolapse. The PRISMA 2020 statement was followed and the review protocol was registered with PROSPERO (CRD42021267941). Studies from inception to 9/2021 were systematically reviewed and included. Data collection, risk of bias, and certainty of evidence were assessed using the standard Cochrane methods. The primary outcome measures were improvements in prolapse and urinary symptoms. Secondary outcomes included surgical safety and reintervention rates for complications and recurrence. The included studies showed a moderate-to-high risk of bias and low certainty of evidence. Owing to their heterogeneity, no meta-analysis was performed. Cure rates for mixed and urge urinary incontinence and apical prolapse were 47.5 % (CI95%:42.4-52.6), 73.8 % (CI95%:61.9-85.7) and 97-100 % respectively, at a mean follow-up of 9.7 ± 7.3 months. Additional incontinence surgery in 38.9 % (216/555) of women with initial urinary incontinence, and concomitant or subsequent surgery for prolapse was performed in 4.4 % (13/299). Cervicosacropexy or vaginosacropexy may remedy symptoms of urge and mixed urinary incontinence and seem to correct apical prolapse in the short term. Nevertheless, the overall level of evidence is low. Therefore, further clinical trials, integrated in the IDEAL framework, targeting better-identified patient selection, and using validated outcome measures are needed.

Large-scale surgical workflow segmentation for laparoscopic sacrocolpopexy.

PURPOSE: Laparoscopic sacrocolpopexy is the gold standard procedure for the management of vaginal vault prolapse. Studying surgical skills and different approaches to this procedure requires an analysis at the level of each of its individual phases, thus motivating investigation of automated surgical workflow for expediting this research. Phase durations in this procedure are significantly larger and more variable than commonly available benchmarks such as Cholec80, and we assess these differences. METHODOLOGY: We introduce sequence-to-sequence (seq2seq) models for coarse-level phase segmentation in order to deal with highly variable phase durations in Sacrocolpopexy. Multiple architectures (LSTM and transformer), configurations (time-shifted, time-synchronous), and training strategies are tested with this novel framework to explore its flexibility. RESULTS: We perform 7-fold cross-validation on a dataset with 14 complete videos of sacrocolpopexy. We perform both a frame-based (accuracy, F1-score) and an event-based (Ward metric) evaluation of our algorithms and show that different architectures present a trade-off between higher number of accurate frames (LSTM, Mode average) or more consistent ordering of phase transitions (Transformer). We compare the implementations on the widely used Cholec80 dataset and verify that relative performances are different to those in Sacrocolpopexy. CONCLUSIONS: We show that workflow segmentation of Sacrocolpopexy videos has specific challenges that are different to the widely used benchmark Cholec80 and require dedicated approaches to deal with the significantly larger phase durations. We demonstrate the feasibility of seq2seq models in Sacrocolpopexy, a broad framework that can be further explored with new configurations. We show that an event-based evaluation metric is useful to evaluate workflow segmentation algorithms and provides complementary insight to the more commonly used metrics such as accuracy or F1-score.