Création d’un registre des complications du traitement chirurgical des prolapsus génitaux

Abstract

ObjectiveData about serious adverse events can be particularly useful when assessing surgical procedures. However, spontaneous reporting of adverse events does not generally provide sufficient or highly accurate data on incidence and prevalence. In order to provide the most complete and accurate data, a postoperative surveillance program for pelvic organ prolapse (POP) surgery was conducted in the region Île-de-France from June through December 2007.Material and methodsThe program included 200 patients who have undergone POP surgery from nine test centers.Serious adverse events were defined following WHO recommendations (mortality, increased hospital stay, reintervention, rehospitalization, unexpected postoperative hospitalization in intensive care unit).ResultsIn 184 cases, it was a primary surgery for POP: laparoscopic sacrocolpopexy (N = 52), sacrocolpopexy by laparotomy (N = 12), and surgical treatment by vaginal approach without mesh (N = 87), with synthetic macroporous monofilament polypropylene mesh (N = 19) or with absorbable biological mesh (N = 14). Furthermore, 16 women have undergone surgery for POP recurrence. Eighteen serious adverse events have been reported between June 2007 and December 2007. Median latency between surgery and observation of a serious adverse event was 18months (IQR: 5–45). The most common adverse events were vaginal extrusion of non absorbable suture following sacrospinous fixation (N = 3), vaginal extrusion of synthetic mesh following the transvaginal placement of nonabsorbable mesh between the bladder and the vagina (N = 6), or vaginal extrusion of a syntheticmesh following sacrocolpopexy (N = 2).ConclusionThe pattern of occurrence of serious adverse events indicates that most complications occur after 6-month follow-up. Furthermore, this study shows that the frequency of serious adverse event commonly reported following POP surgery is probably underestimated. These discrepancies may be explained by the method of monitoring used in the current register study, which reported clinically relevant adverse events.