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Lucot, J‐P; Cosson, M; Verdun, S; Debodinance, P; Bader, G; Campagne‐Loiseau, S; Salet‐Lizee, D; Akladios, C; Ferry, P; De Tayrac, R; Delporte, P; Curinier, S; Deffieux, X; Blanc, S; Capmas, P; Duhamel, A; Fritel, X; Fauconnier, A
BJOG : an international journal of obstetrics and gynaecology, January 2022, 2022-Jan, 2022-01-00, 20220101, 2022, Volume: 129, Issue: 1Journal Article
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 At 4 years, Laparoscopic Sacropexy (LS) had a better benefit–harm balance with fewer re‐interventions due to complications than Trans‐Vaginal Mesh (TVM). Tweetable At 4 years LS had a better benefit–harm balance with fewer re‐interventions due to complications than TVM.
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