Search

Objective: To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair. Design: Prospective cohort study using a registry. Setting: Nineteen French surgical centres. Population: A total of 2309 women participated between 2017 and 2019. Methods: A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups. Main outcome measures: Serious complications and subsequent reoperations for POP recurrence. Results: The median follow‐up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43–6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45–4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13–0.39) and sacropexy (wHR 0.29, 95% CI 0.18–0.47) groups. Conclusions: Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making. Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair. Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years. Design: Extended follow up of a randomised trial. Setting: Eleven centres. Population: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP‐Q], aged 45–75 years without previous prolapse surgery. Methods: Synthetic non‐absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM). Main outcome measures: Functional outcomes (pelvic floor distress inventory [PFDI‐20] as primary outcome); anatomical assessment (POP‐Q), composite outcome of success; re‐interventions for complications. Results: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI‐20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference −7.2 points; 95% CI −14.0 to −0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61–81% versus TVM 71%, 62–81%; hazard ratio 0.92, 95% CI 0.55–1.54; P = 0.75) were similar. POP‐Q measurements did not differ, except for point C (LS −57 mm versus TVM −48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0–4.7%) than after TVM (8.7%, 3.4–13.7%; hazard ratio 4.6, 95% CI 1.007–21.0, P = 0.049)). Conclusions: Both techniques provided improvement and similar success rates. LS had a better benefit–harm balance with fewer re‐interventions due to complications. TVM remains an option when LS is not feasible. At 4 years, Laparoscopic Sacropexy (LS) had a better benefit–harm balance with fewer re‐interventions due to complications than Trans‐Vaginal Mesh (TVM). At 4 years LS had a better benefit–harm balance with fewer re‐interventions due to complications than TVM. [ABSTRACT FROM AUTHOR]

Midurethral slings are the gold standard for treating stress urinary incontinence, but their complications may raise concerns. Complications may differ by the approach used to place them. This study aimed to compare serious complications and reoperations for recurrence after midurethral sling procedures when using the retropubic vs the transobturator route for female stress urinary incontinence. This analysis was of patients included in the French, multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence either by the retropubic or the transobturator route and excluded patients with single-incision slings. Follow-up continued until October 2021. Serious complications (Clavien-Dindo classification ≥ grade III) attributable to the midurethral sling and reoperations for recurrence were compared using Cox proportional hazard models including any associated surgery (hysterectomy or prolapse) and a frailty term to consider the center effect. Baseline differences were balanced by propensity score weighting. Analyses using the propensity score and Cox models were adjusted for baseline differences, center effect, and associated surgery. A total of 1830 participants received a retropubic sling and 852 received a transobturator sling in 27 French centers that were placed by 167 surgeons. The cumulative 2-year estimate of serious complications was 5.8% (95% confidence interval, 4.8–7.0) in the retropubic group and 2.9% (95% confidence interval, 1.9–4.3) in the transobturator group, that is, after adjustment, half of the retropubic group was affected (adjusted hazard ratio, 0.41; 95% confidence interval, 0.3–0.6). The cumulative 2-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% confidence interval, 2.0–3.6) in the retropubic group and 2.8% (95% confidence interval, 1.7–4.2) in the transobturator group with risk for revision for recurrence being higher in the transobturator group after adjustment (adjusted hazard ratio, 1.9; 95% confidence interval, 1.2–2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence. The transobturator route for midurethral sling placement is associated with a lower risk for serious complications but a higher risk for surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring. [ABSTRACT FROM AUTHOR]

Objective: To assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse.Design: Prospective longitudinal cohort study using a surgical registry.Setting: Thirteen public hospitals in France.Population: A cohort of 1873 women undergoing surgery between February 2017 and August 2018.Methods: Preliminary analysis of serious complications after a mean follow-up of 7 months (0-18 months), according to type of surgery. Surgeons reported procedures and complications, which were verified by the hospitals' information systems.Main Outcome Measures: Serious complication requiring discontinuation of the procedure or subsequent surgical intervention, life-threatening complication requiring resuscitation, or death.Results: Fifty-two women (2.8%, 95% CI 2.1-3.6%) experienced a serious complication either during surgery, requiring the discontinuation of the procedure, or during the first months of follow-up, necessitating a subsequent reoperation. One woman also required resuscitation; no women died. Of 811 midurethral slings (MUSs), 11 were removed in part or totally (1.4%, 0.7-2.3%), as were two of 391 transvaginal meshes (0.5%, 0.1-1.6%), and four of 611 laparoscopically placed mesh implants (0.7%, 0.2-1.5%). The incidence of serious complications 6 months after the surgical procedure was estimated to be around 3.5% (2.0-5.0%) after MUS alone, 7.0% (2.8-11.3%) after MUS with prolapse surgery, 1.7% (0.0-3.8%) after vaginal native tissue repair, 2.8% (0.9-4.6%) after transvaginal mesh, and 1.0% (0.1-1.9%) after laparoscopy with mesh.Conclusions: Early serious complications are relatively rare. Monitoring must be continued and expanded to assess the long-term risk associated with mesh use and to identify its risk factors.Tweetable Abstract: Short-term serious complications are rare after surgery for urinary incontinence or pelvic organ prolapse, even with mesh. [ABSTRACT FROM AUTHOR]

Background Progress in diagnostic assessment made it possible to diagnose ASD at a young age. Concurrently, intervention research for toddlers with ASD has increased since the past decade. Method In this study, we report on a five-level meta-analysis of 34 single-subject experimental studies, intended to offer a better insight into what types of interventions are effective for toddlers under the age of three with or at risk for ASD. Results The analysis revealed a significant positive overall effect size. We found that interventions at home were significantly more effective compared to those in other settings. Other significant moderators regarding intervention characteristics were the agent of intervention and duration in weeks. No moderator effects of study and child characteristics were found. Conclusions On average, interventions for toddlers with or at risk for ASD are successful. [ABSTRACT FROM AUTHOR]