This application responds to the broad challenge area of Comparative Effectiveness Research. The Specific Challenge Topic, Comparative Effectiveness of Robotic Surgery (05-EB-104), is addressed. Compared to standard abdominal sacrocolpopexy, the classic gold standard operation for vaginal apical prolapse, minimally-invasive robotic sacrocolpopexy has the potential to provide a safer and more precise treatment, with less patient morbidity. The overall goal of this study is to compare outcomes of the robotic sacrocolpopexy with traditional open sacrocolpopexy, with emphasis on time to return to activities, patient safety, pain scores, and cost. We hypothesize that, although the cost of robotic sacrocolpopexy exceeds that of open techniques, patients undergoing robotic techniques report an earlier return to normal activities and have significantly less post- operative pain. When societal costs (such as lost work-days) are also included, robotic approaches are less expensive than open approaches. The first aim of this study is to compare the time to return to normal activities between women undergoing open versus robotic sacrocolpopexy. Patients with vaginal vault prolapse will be randomized to either an open or robotic abdominal sacrocolpopexy. Return to normal activities will be measured using the Medical Outcomes Study Physical and Mental Health Survey Acute Form (SF-12, version 2) given on a weekly basis for 6 post-operative weeks. Next, a cost-effectiveness analysis will be performed in order to compare all costs between an open versus robotic approach to sacrocolpopexy. Costs of care will be compared between the two treatment arms by a specific cost analysis of billing records. A cost- effectiveness analysis will be performed that measures both costs and quality adjusted life years (QALYs) for each treatment arm. We will then compare post-operative pain, as measured by post operative narcotic usage and visual analog pain scores, between the two groups. Patient safety between robotic and open sacrocolpopexy techniques will also be compared, including immediate intra-operative and post-operative complications, length of surgery, and blood loss. This study's last goal is to compare the intermediate term efficacy between robotic and open sacrocolpopexy, based on physical examination and prolapse symptom bother at three months, six months, one year, and two years after surgery. The degree of pelvic organ prolapse will be quantified pre-operatively with the Pelvic Organ Prolapse Quantification (POPQ) system. Degree of bother from prolapse symptoms will be measured using the Pelvic Floor Distress Inventory (PFDI) Short Form questionnaire. At three months, six months, one year and at two years after surgery, patients will be re-examined for recurrent prolapse using the POPQ system, and will again be given the PFDI Short Form.

PUBLIC HEALTH RELEVANCE: Although robotic technology is new and rapidly spreading throughout the urologic and gynecologic communities, there have been no randomized trials comparing outcomes of robotic versus open sacrocolpopexy for vaginal prolapse. The primary aim of this study is to compare short-term outcomes of robotic versus open sacrocolpopexy with respect to patient convalescence. Secondary aims will include a direct comparison of patient safety, costs through a cost-effectiveness analysis, and post-operative pain.

RC1EB010649

2009-09-30

2012-08-31