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.

Posterior rectus fascia prolapse (PREFAP) repair: a new native tissue approach to pelvic organ prolapse via vaginal natural orifice transluminal endoscopic surgery.

INTRODUCTION: Pelvic organ prolapse (POP) is a common condition in women. During lifetime, up to 40% of all women will develop (POP). MATERIALS AND METHODS: Between June and December 2021, five patients were successfully treated via vNOTES Posterior Rectus Fascia Prolapse ( PREFAP) repair. No intra-operative complications or conversions occurred. CONCLUSION: In this study we demonstrated a new technique for prolapse repair, harvesting the autologous posterior rectus fascia sheath via vaginal natural orifice transluminal endoscopic surgery (vNOTES) as an alternative for a synthetic mesh.

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.

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.

Standardized 10-step approach for successfully performing a hysterectomy via vaginal natural orifice transluminal endoscopic surgery.

Vaginal natural orifice transluminal endoscopic surgery (NOTES) is a novel technique for minimally invasive gynecological surgery. Adequate training and standardization are key elements to patient safety and quality of care. Based on consensus statements and expert opinion; we report a step-by-step guidance for hysterectomy via natural orifice transluminal endoscopy. A detailed description is presented of pre- and postoperative care, and the instruments and equipment used, and surgical steps are illustrated by photographic images. This report can guide surgeons in their training to perform a hysterectomy via NOTES.

Pregnancy Outcome after Vaginal Natural Orifice Transluminal Endoscopic Surgery, a First Retrospective Observational Cohort Study.

STUDY OBJECTIVE: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimal invasive surgical technique allowing a variety of gynecological procedures. The current literature describes improved patient comfort, improved better cosmetic results, and reduced operation time. This is a first study to assess pregnancy outcome after fertility-preserving vNOTES procedures. Design/Participants/Materials/Setting/Methods: We performed a retrospective observational cohort study including 125 patients under 43 years that underwent fertility-preserving vNOTES over a 5-year period (2014-2019). The gynecological surgical procedures included were vNOTES myomectomy, vNOTES salpingectomy for ectopic pregnancy, vNOTES unilateral adnexectomy, and vNOTES cystectomy. A total of 26 pregnancies in 21 cases were observed, with deliveries between 2015 and 2020. RESULTS: Retrospective analysis in this patient group showed that 18 pregnancies were diagnosed within 1 year after vNOTES (85.7%). Mean interval between surgery and pregnancy was 6 months. Fertility treatment was performed in 28.6%. In the 26 observed pregnancies, no vNOTES-related complications were observed and delivery was at term in all cases. Mode of delivery was a vaginal delivery in twenty cases (76.9% of total) of which 2 cases vacuum assisted (7.7%) and a Caesarean section in 6 cases (23.1% of total). Two cases of trial of labor after Caesarean are described after vNOTES surgery, both ended in an uncomplicated vaginal delivery. In case of vaginal delivery, the perineum was intact in 15%, a mediolateral episiotomy was performed in 50 and 35% a grade 1-2 perineal rupture was described. No grade 3-4 perineal ruptures are described. LIMITATIONS: A limitation of this study is the retrospective design which does not correct for confounding factors. Further larger multicenter studies are needed to validate these data. CONCLUSIONS: This is the first study describing pregnancy outcome after fertility-preserving vNOTES procedures. vNOTES did not affect the mode of delivery or cause pregnancy-related complications. vNOTES did not increase the risk of extensive perineal tears during vaginal delivery. These preliminary data show no adverse events when vNOTES is performed in women of reproductive age. Posterior colpotomy as performed in all vNOTES procedures is by itself not an indication for an elective Caesarean section.

Systematic Review and Meta-Analysis on Hysterectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Laparoscopic Hysterectomy for Benign Indications.

(1) Objective: We aimed to report an update of the systematic review and meta-analysis by Baekelandt et al. (2016). (2) Method: We followed PRISMA guidelines to perform this systematic review. We searched MEDLINE, EMBASE, CENTRAL and additional sources and aimed to retrieve randomised controlled trials (RCTs), controlled clinical trials (CCTs) and prospective/retrospective cohort studies in human subjects that allowed direct comparison of vNOTES to laparoscopy. (3) Results: Our search yielded one RCT and five retrospective cohort trials. Pooled analysis of two subgroups showed that, compared to conventional laparoscopy, vNOTES is equally effective to successfully remove the uterus in individuals meeting the inclusion criteria. vNOTES had significantly lower values for operation time, length of stay and estimated blood loss. There was no significant difference in intra- and postoperative complications, readmission, pain scores at 24 h postoperative and change in hemoglobin (Hb) on day 1 postoperative.

Intrauterine Fluid Instillation and Transtubal Flow: A Randomized Controlled In vitro Trial Comparing Gel and Water.

BACKGROUND: Possible transtubal spillage of malignant cells is a major concern in fluid instillation sonography, as it is in hysteroscopy. This study aims to compare the transtubal flow of gel and saline and validate the clinical hypothesis that application of fluids with higher viscosity causes less spillage. METHODS: Randomized controlled in vitro trial comparing gel and saline infusion on 15 tissue specimens after hysterectomy with bilateral salpingectomy. Instillations are performed with saline and gel dyed with a 1% ink solution. Qualitative assessment of tubal spill is investigated as primary outcome. Secondary outcomes are instillation-volume and -pressure, assessed by measuring endometrial cavity dilation at in vitro ultrasound examination and subjective numeric 10-point scoring of the instillation pressure by a dedicated examiner. RESULTS: Tubal flow was more often observed during saline instillation (odds ratio 4.88, P = 0.008). Median subjectively assessed instillation pressures were nine arbitrary units for gel and three for saline (P < 0.001). Tubal flow occurred from 2 cc onward in the saline group versus five cc in the gel instillation group. Cavitary dilation did not differ between both groups. CONCLUSION: Gel instillation sonography is in vitro associated with less tubal flow and therefore could be a safer diagnostic test compared to saline infusion sonography or hysteroscopy. In vivo studies are necessary to confirm these results.

Survey on surgery for stress urinary incontinence in an era mid-urethral slings are being questioned.

INTRODUCTION: Concerns about vaginal mesh have reduced the use of mid-urethral slings (MUS) in some countries. In view of their potential withdrawal in Belgium and The Netherlands, we polled urogynaecologists on their practice for treating stress urinary incontinence (SUI) and what their experience is with alternative procedures, and we asked them how their patients perceive the risk and success rates. METHODS: A survey among members of the pelvic floor special interest group of the Flemish Society for Obstetrics and Gynaecology, Belgian Association of Urology and Dutch Society of Obstetrics and Gynaecology. RESULTS: Their primary procedure of choice is the MUS (99%). Sixty-five per cent performs at least 25 MUS yearly; they report high success (90%; IQR [85-92]) and low adverse outcome rates. Physicians anticipate complications as reported in the literature: 5% (IQR [410]) overactive bladder, 5% (IQR [2-10]) voiding problems, 2% (IQR [15]) exposures, 2% (IQR [1-5]) dyspareunia and 1% (IQR [1-3]) chronic pain. Eighty-five per cent of physicians report their patients express fears about having a MUS though usually they cannot precisely tell why. Reportedly they tell their physicians of concerns about pain (54%), exposure (45%), dyspareunia (25%), voiding problems (15%) or overactive bladder (8%). Only half of respondents had ever performed a colposuspension. The majority of these were older and performed colposuspension via laparotomy. Only six (4%) had performed > 20 colposuspensions yearly. CONCLUSION: Dutch and Belgian urogynaecologists estimate success and adverse effect rates of MUS in line with the literature. Their patients most cited worries were fear of chronic pain and exposure. Only half of respondents had ever performed a colposuspension. They were older and performed the procedure via laparotomy.

Medium-term outcome of laparoscopic sacrocolpopexy using polivinylidene fluoride as compared to a hybrid polyglecaprone and polypropylene mesh: A matched control study.

AIM: To compare 2-year outcomes of laparoscopic sacrocolpopexy (LSCP) either with polyvinylidene fluoride (PVDF) or hybrid polypropylene containing a resorbable polyglecaprone (PP+ PG) mesh. MATERIALS AND METHODS: Retrospective audit on 105 consecutive patients undergoing LSCP a with PVDF-mesh (DynaMesh, FEG Textiltechniken), matched by prolapse stage and cervicopexy or vault suspension to 105 controls undergoing LSCP with a hybrid PP + PG-mesh (Ultrapro, Ethicon). Patients are part of an ongoing prospective study. The primary outcome measure was the Patient Global Impression of Change score (PGIC), the coprimary variable was failure rate at the vault (≤1 cm). Other outcomes were intraoperative and postoperative complications within 3 months categorized by the Clavien-Dindo classification, reinterventions, graft-related complications (GRCs) and functional outcomes. All assessments were performed by an independent assessor. Data are reported as median (interquartile range) number and percent as appropriate, the Mann-Whitney U, χ2 , or Fisher exact were used for comparison. RESULTS: Patient satisfaction in the PVDF group, as measured with the PGIC, was high (90.9% PGIC, ≥4) as well as was the anatomical success (97.3%) at a follow-up of 26 months. These outcomes were comparable to those of PP + PG-patients (84.8% PGIC, ≥4; 94.9% anatomical success). There were five patients (2.4%) with Dindo-III or higher complications and three patients had GRCs (1.5%), without differences between mesh type. Level-II posterior defects (Bp ≥ -1) were less likely in PVDF patients (34.1% vs 50% for PP + PG-patients; P = .003). Women in the PVDF group also were less bothered by prolapse (7.5% vs 26.4%; P = .001), yet they complained more of constipation (15.0% vs 9.0%; P = .01). CONCLUSION: There were no differences in patient satisfaction and anatomical outcomes after LSCP either with PVDF or PP + PG mesh.

Ultrasound visualization of sacrocolpopexy polyvinylidene fluoride meshes containing paramagnetic Fe particles compared with polypropylene mesh.

INTRODUCTION AND HYPOTHESIS: Paramagnetic Fe particles can be added during synthetic mesh production to allow visibility on magnetic resonance imaging. Our aim was to evaluate whether transperineal ultrasound (TPUS) allows visualization, measurement, and characterization of polyvinylidene fluoride (PVDF mesh) containing Fe particles compared with regular polypropylene (PP) meshes used for sacrocolpopexy. METHODS: Women up to 1.5 years after laparoscopic sacrocolpopexy who were implanted with a PP or PVDF mesh underwent clinical examination and 2D, 3D, and 4D TPUS. Acquired volumes were analyzed offline for mesh position at rest and maximal Valsalva and for mesh dimensions and characteristics, with the operator blinded to group assignment. The two groups were compared. RESULTS: There were 17 women in the PP and 25 in the PVDF mesh group, without differences in baseline demographics. None had significant prolapse, recurrence, symptoms, or complications. On TPUS, mesh was visible in all patients both caudally (perineal) and cranially but was more echogenic in the PVDF mesh group. Mesh length from distal to proximal that was visible on TPUS was longer for PVDF mesh, for both anterior and posterior vaginal arms (all P < 0.05), and for mesh above the vaginal apex (P = 0.002). The inferior aspects of the mesh showed areas of double mesh layers, suggesting folding in 80% of women in both groups, without symptoms. CONCLUSIONS: PVDF mesh permits clearer visualization and is seen over a longer stretch on TPUS, with longer visible mesh arms. The latter can be due to differences in operative technique, presence of microparticles, implant textile structure, or patient characteristics.

Short term post-operative morphing of sacrocolpopexy mesh measured by magnetic resonance imaging.

BACKGROUND: Sacrocolpopexy (SC) involves suspension of the vaginal vault or cervix to the sacrum using a mesh. Following insertion, the meshes have been observed to have undergone dimensional changes. OBJECTIVE: To quantify dimensional changes of meshes following implantation and characterize their morphology in-vivo. DESIGN SETTING AND PARTICIPANTS: 24 patients underwent SC using PolyVinyliDeneFluoride mesh loaded with Fe3O4 particles. Tailored anterior and posterior mesh flaps were sutured to the respective vaginal walls, uniting at the apex. The posterior flap continued to the sacrum and was attached there. Meshes were visualized on magnetic resonance (MR) imaging at 12 [3-12] (median [range]) months postoperatively and 3D models of the mesh were generated. Dynamic MR sequences were acquired during valsalva to record mesh mobility. OUTCOME MEASURES: The area of the vagina effectively supported by the mesh (Effective Support Area (ESA)) was calculated. The 3D models' wall thickness map was analyzed to identify the locations of mesh folding. Intraclass correlation (ICC) was calculated to test the reliability of the methods. To measure the laxity and flatness of the mesh, the curvature and the ellipticity of the sacral flap were calculated. RESULTS: The ESA calculation methodology had ICC = 0.97. A reduction of 75.49 [61.55-78.67] % (median [IQR]) in area, 47.64 [38.07-59.81] % in anterior flap, and of 23.95 [10.96-27.21] % in the posterior flap was measured. The mesh appeared thicker near its attachment at the sacral promontory (n = 19) and near the vaginal apex (n = 22). The laxity of the mesh was 1.13 [1.10-1.16] and 60.55 [49.76-76.25] % of the sacral flap was flat. We could not reliably measure mesh mobility (ICC = 0.16). CONCLUSION: A methodology for complete 3D characterization of SC meshes using MR images was presented. After implantation, the supported area is much lower than what is prepared prior to implantation. We propose this happened during the surgery itself.

Laparoscopic versus robotic-assisted sacrocolpopexy for pelvic organ prolapse: a systematic review.

The use of robot-assisted surgery (RAS) has gained popularity in the field of gynaecology, including pelvic floor surgery. To assess the benefits of RAS, we conducted a systematic review of randomized controlled trials comparing laparoscopic and robotic-assisted sacrocolpopexy. The Cochrane Library (1970-January 2015), MEDLINE (1966 to January 2015), and EMBASE (1974 to January 2015) were searched, as well as ClinicalTrials.gov and the International Clinical Trials Registry Platform. We identified two randomized trials (n = 78) comparing laparoscopic with robotic sacrocolpopexy. The Paraiso 2011 study showed that laparoscopic was faster than robotic sacrocolpopexy (199 ± 46 vs. 265 ± 50 min; p < .001), yet in the ACCESS trial, no difference was present (225 ± 62.3 vs. 246.5 ± 51.3 min; p = .110). Costs for using the robot were significantly higher in both studies, however, in the ACCESS trial, only when purchase and maintenance of the robot was included (LSC US$11,573 ± 3191 vs. RASC US$19,616 ± 3135; p < .001). In the Paraiso study, RASC was more expensive even without considering those costs (LSC US$ 14,342 ± 2941 vs. RASC 16,278 ± 3326; p = 0.008). Pain was reportedly higher after RASC, although at different time points after the operation. There were no differences in anatomical outcomes, pelvic floor function, and quality of life. The experience with RASC was tenfold lower than that with LSC in both studies. The heterogeneity between the two studies precluded a meta-analysis. Based on small randomized studies, with surgeons less experienced in RAS than in laparoscopic surgery, robotic surgery significantly increases the cost of a laparoscopic sacrocolpopexy. RASC would be more sustainable if its costs would be lower. Though RASC may have other benefits, such as reduction of the learning curve and increased ergonomics or dexterity, these remain to be demonstrated.