Jean-Philippe Lucot1, Michel Cosson2, Georges Bader3, Philippe Debodinance4, Cherif Akladios5, Delphine Salet-Lizée6, Patrick Delporte4, Denis Savary7, Philippe Ferry8, Xavier Deffieux9, Sandrine Campagne-Loiseau7, Renaud de Tayrac10, Sébastien Blanc11, Sandrine Fournet12, Arnaud Wattiez5, Richard Villet6, Marion Ravit13, Bernard Jacquetin7, Xavier Fritel14, Arnaud Fauconnier15. 1. Service de Gynécologie médico chirurgicale Pôle Femme, mère, nouveau-né, Hôpital Jeanne de Flandre, CHRU de Lille, France. Electronic address: jean-philippe.lucot@chru-lille.fr. 2. Service de Gynécologie médico chirurgicale Pôle Femme, mère, nouveau-né, Hôpital Jeanne de Flandre, CHRU de Lille, France. 3. Service de gynécologie-obstétrique CHI Poissy-St-Germain, Université Versailles Saint-Quentin, Poissy, France. 4. Centre Hospitalier de Dunkerque, Dunkerque, France. 5. CHU de Strasbourg, Strasbourg, France. 6. Groupe Hospitalier Diaconesses Croix St-Simon, Paris, France. 7. CHU Estaing, Clermont-Ferrand, France. 8. Service de Gynécologie Obstétrique, Centre Hospitalier, La Rochelle, France. 9. Service de Gynécologie Obstétrique Hôpital Bicêtre, Le Kremlin Bicêtre, France. 10. Hôpital Carémeau CHU de Nîmes, Nîmes, France. 11. Service de Gynécologie, Centre Hospitalier de la Région d'Annecy, Pringy, France. 12. Hôpital Antoine Béclère, Clamart, France. 13. Unité de recherche EA 7285, Université Versailles St-Quentin, Montigny-le-Bretonneux, France. 14. Université de Poitiers, INSERM CIC 1402, CHU de Poitiers, Poitiers, France. 15. Service de gynécologie-obstétrique CHI Poissy-St-Germain, Université Versailles Saint-Quentin, Poissy, France; Unité de recherche EA 7285, Université Versailles St-Quentin, Montigny-le-Bretonneux, France.
Abstract
BACKGROUND:Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. OBJECTIVE: To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45-75 yr, without previous prolapse surgery. INTERVENTION: Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rate of surgical complications ≥grade II according to the modified Clavien-Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results. RESULTS AND LIMITATIONS: A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI -1.5 to 18]; p=0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p=0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI -0.4 to 13.3]; p=0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS). CONCLUSIONS:LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS. PATIENT SUMMARY: Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.
RCT Entities:
BACKGROUND: Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes. OBJECTIVE: To compare the rate of complications, and functional and anatomical outcomes between LS and TVM. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45-75 yr, without previous prolapse surgery. INTERVENTION: Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rate of surgical complications ≥grade II according to the modified Clavien-Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results. RESULTS AND LIMITATIONS: A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI -1.5 to 18]; p=0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS=0.8%, TVM=9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p=0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS=4.7%, TVM=10.9%, treatment difference 6.3% [95% CI -0.4 to 13.3]; p=0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS). CONCLUSIONS:LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS. PATIENT SUMMARY: Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.
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