Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse

Objective: To evaluate the rates of serious complications and reoperation for recurrence following sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse. Methods: This was a national registry ancillary cohort comparative study. The VIGI-MESH registry includes data from 24 French health centers prospectively collected between May 2017 and September 2021. Time to occurrence of a serious complication or reoperation for genital prolapse recurrence was explored using the Kaplan–Meier curve and Log-rank test. The inverse probability of treatment weighting, based on propensity scores, was used to adjust for between-group differences. Results: A total of 1359 women were included and four surgical groups were analyzed: Anterior SSLF with mesh (n = 566), Anterior SSLF with native tissue (n = 331), Posterior SSLF with mesh (n = 57), and Posterior SSLF with native tissue (n = 405). Clavien–Dindo Grade III complications or higher were reported in 34 (2.5%) cases, with no statistically significant differences between the groups. Pelvic organ prolapse recurrence requiring re-operation was reported in 44 (3.2%) women, this was higher following posterior compared with anterior SSLF (p = 0.0034). Conclusions: According to this large database ancillary study, sacrospinous ligament fixation is an effective and safe surgical treatment for apical prolapse. The different surgical approaches (anterior/posterior and with/without mesh) have comparable safety profiles. However, the anterior approach and the use of mesh were associated with a lower risk of reoperation for recurrence compared with the posterior approach and the use of native tissue, respectively

Complications after pelvic floor repair surgery (with and without mesh): short-term incidence after 1873 inclusions in the French VIGI-MESH registry.

International audienceOBJECTIVE:Assess the short-term incidence of serious complications of surgery for urinary incontinence or pelvic organ prolapse.DESIGN:Prospective longitudinal cohort study by using a surgical registry.SETTING:13 public hospitals in France.POPULATION OR SAMPLE:1873 women undergoing surgery between February 2017 and August 2018.METHODS:Preliminary analysis of serious complications after a mean 7-month follow-up (0-18), 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:52 women (2.8%, 95% CI 2.1-3.6) experienced a serious complication during either the surgery, requiring discontinuation of the procedure, or the first months of follow-up, necessitating a subsequent reoperation; one case also required resuscitation; no women died. Of 811 midurethral slings (MUS), 11 were removed in part or totally (1.4%, 0.7-2.3), as were 2 of 391 transvaginal meshes (0.5%, 0.1-1.6), and 4 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 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 enlarged to assess the long-term risk associated with mesh use and identify its risk factors

Complications sérieuses et récidives après bandelette sous-urétrale par voie rétropubienne versus transobturatrice pour 2682 patientes participant au registre VIGI-MESH

International audienceBackground: 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.Objective(s): To compare serious complications and reoperations for recurrence after midurethral sling procedures by the retropubic and transobturator routes for female stress urinary incontinence.Study Design: This analysis covers patients included in the French multicenter VIGI-MESH register since February 2017 who received a midurethral sling for female stress urinary incontinence by the retropubic or transobturator route, excluding single-incision slings. Follow-up continued to October 2021. Serious complications (Clavien-Dindo classification ≥ Grade III) imputable to the midurethral sling and reoperations for recurrence were compared by 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.Results: 1830 participants received a retropubic sling and 852 a transobturator sling in 134 French centers, placed by 167 surgeons. The cumulative two-year estimate of serious complications was 5.8% (95% CI 4.8-7.0%) in the retropubic group and 2.9% (95% CI 1.9–4.3%) in the transobturator group, that is, after adjustment, half that of the retropubic group (adjusted HR 0.41; 95% CI 0.3-0.6). The cumulative two-year estimate of reoperation for recurrence of stress urinary incontinence was 2.7% (95% CI 2.0-3.6) in the retropubic group and 2.8% (95% CI 1.7-4.2) in the transobturator group, with risk of revision for recurrence higher in the transobturator group after adjustment (adjusted HR 1.9; 95% CI 1.2-2.9); this surplus risk disappeared after exclusion of the patients with a previous surgery for stress urinary incontinence.Conclusions: The transobturator route for midurethral slings is associated with a lower risk of serious complications but a higher risk of surgical reoperation for recurrence than the retropubic route. Despite the large number of surgeons involved, these risks were low. The data are therefore reassuring