J-P Lucot1, M Cosson2, S Verdun3, P Debodinance4, G Bader5, S Campagne-Loiseau6, D Salet-Lizee7, C Akladios8, P Ferry9, R De Tayrac10, P Delporte4, S Curinier6, X Deffieux11, S Blanc12, P Capmas13, A Duhamel14, X Fritel15, A Fauconnier4,16. 1. Service de gynécologie-obstétrique, Hôpital Saint Vincent de Paul, Groupe des Hôpitaux de l'Institut Catholique de Lille (GHICL), Lille, France. 2. Service de Gynécologie médico chirurgicale Pôle Femme, mère, nouveau-né, Hôpital Jeanne de Flandre, CHRU de Lille, France. 3. Biostatistics Department-Delegation for Clinical Research and Innovation, Lille Catholic Hospitals, Lille Catholic University, Lille, France. 4. Centre Hospitalier de Dunkerque, Dunkerque, France. 5. Service de gynécologie-obstétrique CHI Poissy-St-Germain, Université Versailles Saint-Quentin, Poissy, France. 6. CHU Estaing, Clermont-Ferrand, France. 7. Groupe Hospitalier Diaconesses Croix St-Simon, Paris, France. 8. CHU de Strasbourg, Strasbourg, France. 9. Service de Gynécologie Obstétrique, Centre Hospitalier, La Rochelle, France. 10. Hôpital Carémeau CHU de Nîmes, Nîmes, France. 11. Hôpital Antoine Béclère, Clamart, France. 12. Service de Gynécologie, Centre Hospitalier de la Région d'Annecy, Pringy, France. 13. Service de Gynécologie Obstétrique Hôpital Bicêtre, Le Kremlin Bicêtre, France. 14. Univ Lille, CHU Lille, ULR 2694 METRICS, Lille, France. 15. Université de Poitiers, INSERM CIC 1402, CHU de Poitiers, Poitiers, France. 16. Unité de recherche EA 7285, Université Versailles St-Quentin, Montigny-le-Bretonneux, France.
Abstract
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. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).
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. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).
Authors: Renaud de Tayrac; Michel Cosson; Laure Panel; Clara Compan; Mohammed Zakarya Zemmache; Sophie Bouvet; Laurent Wagner; Brigitte Fatton; Géry Lamblin Journal: Int Urogynecol J Date: 2022-01-19 Impact factor: 1.932