X Fritel1,2, S Campagne-Loiseau3, M Cosson4, P Ferry5, C Saussine6, J-P Lucot7, D Salet-Lizee8, M-L Barussaud9, T Boisramé10, C Carlier-Guérin11, T Charles12, P Debodinance13, X Deffieux14, A-C Pizzoferrato15, S Curinier3, S Ragot16, V Ringa2, R de Tayrac17, A Fauconnier18. 1. INSERM CIC 1402, CHU de Poitiers, Service de gynécologie-obstétrique, Université de Poitiers, Poitiers, France. 2. CESP Inserm U1018, Paris, France. 3. CHU Estaing, Service de gynécologie-obstétrique, Clermont-Ferrand, France. 4. CHU de Lille, Service de gynécologie-obstétrique, Université de Lille, Lille, France. 5. CH de La Rochelle, Service de gynécologie-obstétrique, La Rochelle, France. 6. CHU de Strasbourg, Service d'urologie, Université de Strasbourg, Strasbourg, France. 7. Hôpital Saint-Vincent-de-Paul, Service de gynécologie-obstétrique, Lille, France. 8. Groupe Hospitalier Diaconesses-Croix-Saint-Simon, Service de gynécologie, Paris, France. 9. CHU de Poitiers, Service de chirurgie viscérale, Poitiers, France. 10. CHU de Strasbourg, Service de gynécologie-obstétrique, Strasbourg, France. 11. CH de Châtellerault, Service de gynécologie-obstétrique, Châtellerault, France. 12. CHU de Poitiers, Service d'urologie, Poitiers, France. 13. CH de Dunkerque, Service de gynécologie-obstétrique, Dunkerque, France. 14. APHP Antoine-Béclère, Service de gynécologie-obstétrique, Université Paris-Sud, Clamart, France. 15. CHU de Caen, Service de gynécologie-obstétrique, Caen, France. 16. INSERM CIC 1402, Université de Poitiers, Poitiers, France. 17. CHU Carémeau, Service de gynécologie-obstétrique, Université de Nîmes, Nîmes, France. 18. CHI Poissy-Saint-Germain, Service de gynécologie-obstétrique, UVSQ, Poissy, France.
Abstract
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.
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.
Authors: Ismaiel Abu Mahfouz; Ibtehal Abu Shabab; Heba Abu Saleem; Salem Abu Mahfouz; Qasem Shehab; Fida Asali Journal: Sultan Qaboos Univ Med J Date: 2020-12-21