Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance in Female Patients With Symptomatic Pelvic Organ Prolapse Using an Outpatient Treatment Model

What this Trial Is About

Pelvic organ prolapse is a common condition affecting 30 to 40% of women, with about 12% experiencing symptoms that impact their psychological, physical, and social well-being. Laparoscopic sacrocolpopexy is considered the surgical gold standard treatment, aiming to support the vaginal vault using a prosthesis. The procedure shows a high patient satisfaction rate of 94% and a low overall complication rate of 11%. This study focuses on evaluating the success of outpatient laparoscopic sacrocolpopexy, with or without robotic assistance, in women with symptomatic pelvic organ prolapse. The study is a national multicenter prospective trial including 80 female patients aged 40 to 80 years with significant prolapse. Patients will undergo outpatient laparoscopic sacrocolpopexy, either with or without robotic assistance. Outpatient success is defined by no need for inpatient admission within 24 hours after surgery, based on specific clinical criteria such as CHUNG score, absence of perioperative complications, and no urinary retention requiring catheter reinsertion. The surgical procedure remains the same as in hospital, but patients will return home the same day if their condition allows. Participants will be followed for one month, with a postoperative visit at 30 days to assess the effectiveness of the surgery using standard measures like POP-Q and several quality-of-life questionnaires. Researchers will monitor the success rate of outpatient treatment and the percentage of failures within the 24-hour post-surgery period. This preliminary study aims to establish a reference for successful outpatient sacrocolpopexy, potentially guiding larger trials comparing outpatient and inpatient treatments for pelvic organ prolapse.

AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.