MP02-12 A MULTICENTER RANDOMIZED TRIAL COMPARING ROBOT-ASSISTED VERSUS PURE LAPAROSCOPIC SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE.

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You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse (MP02)1 Apr 2019MP02-12 A MULTICENTER RANDOMIZED TRIAL COMPARING ROBOT-ASSISTED VERSUS PURE LAPAROSCOPIC SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE. Laurent Wagner, Serge Douvier, Alain Ruffion, Christian Saussine, Laurent Soustelle, Jerome Rigaud, Guillaume Meurette, Emmanuel Chartier-Kastler, Adrien Vidart, Andrea Manunta, Etienne Vincens, Maxence Dorez, Mélanie Cayrac, Jean-Luc Hoepffner, Pierre Costa, and Stéphane Droupy* Laurent WagnerLaurent Wagner More articles by this author , Serge DouvierSerge Douvier More articles by this author , Alain RuffionAlain Ruffion More articles by this author , Christian SaussineChristian Saussine More articles by this author , Laurent SoustelleLaurent Soustelle More articles by this author , Jerome RigaudJerome Rigaud More articles by this author , Guillaume MeuretteGuillaume Meurette More articles by this author , Emmanuel Chartier-KastlerEmmanuel Chartier-Kastler More articles by this author , Adrien VidartAdrien Vidart More articles by this author , Andrea ManuntaAndrea Manunta More articles by this author , Etienne VincensEtienne Vincens More articles by this author , Maxence DorezMaxence Dorez More articles by this author , Mélanie CayracMélanie Cayrac More articles by this author , Jean-Luc HoepffnerJean-Luc Hoepffner More articles by this author , Pierre CostaPierre Costa More articles by this author , and Stéphane Droupy*Stéphane Droupy* More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000554924.71301.baAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Pelvic organ prolapse (POP) is a frequent and invalidating condition in women, and surgery is an option for women with troublesome prolapse. The challenge in prolapse repair surgery is to restore women well-being, self-image, and quality of life without inducing adverse effects or sequelae. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard. Since the introduction of robotic-assisted sacrocolpopexy (RAS) in 2006, this approach has gain interest and 21000 procedures have been undergone in 2017 worldwide. Retrospective and under-powered prospective comparative studies indicated that robotic-assistance is associated with a reduced risk of complications, shorter hospital stay and a shorter learning curve but increased costs as compared with LS. METHODS: We report the results of a multicenter, randomized, controlled trial (clinicalTrials.gov number, NCT 01320215) designed to assess whether RAS would be associated with a lower rate of perioperative complications than pure LS. Patient with a first (primo-event), symptomatic, genitourinary prolapse of at least stage II (POP-Q classification) requiring surgery, were recruited in 16 centers from July 2011 to October 2016. All the surgeons participating in the study were experienced in pure LS (at least 20 cases) and RAS (at least 10 cases). The primary objective was to compare 30-day complication rates and secondary objectives included comparing technical data, anatomical correction, recurrence, incontinence, quality of life and medico-economic data between arms, during 5 years follow up. Complications were defined as at least one of the following surgical complications (bleeding complications: hemoperitoneum, blood loss ≥ 500 ml, transfusion; any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; trocart sites: infection, hernia; conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; reintervention) or medical complications (deep vein thrombosis, pulmonary embolism, pneumopathy, urinary tract infection;