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

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; chronic pain) RESULTS: overall, 345 patients were randomly assigned to both arms (170 RAS, 175 LS). On the basis of an intent to treat analysis, we found that 20 patients (11,76%) in the RAS group and 27 patients in the LS group (15,43%) had complications (P=0.3213). Surgical complications were found in 6 patients (3,5%) in the RAS and 16 (9,1%) in the LS group (P=0,04). Length of surgery, anesthesia and hospital stay were similar between groups. However, when a complication occured the mean hospital stay was 5.6 days in the LS group and 3.8 in the RAS group (P=0,01). Median experience of surgeons was 60 cases for LS and 20 cases for RAS. CONCLUSIONS: this randomized controlled trial showed similar rates of perioperative complications and lenght of hospital stay among patients who underwent RAS or LS. However, RAS group showed less surgical complications despite less experienced surgeons suggesting that the robot provides at least similar surgical skills with a shorter learning curve