Increasing the Utility of Contrast Agents for MRI

描述（由申请人提供）：本申请响应比较有效性研究的广泛挑战领域。具体的挑战主题，机器人手术的比较有效性（05-EB-104），被解决。与阴道根尖脱垂的经典金标准手术——标准腹腔骶colpop固定术相比，微创机器人骶colpop固定术有可能提供更安全、更精确的治疗，患者发病率更低。本研究的总体目标是比较机器人骶髋固定术与传统开放式骶髋固定术的结果，重点是恢复活动的时间、患者安全性、疼痛评分和成本。我们假设，尽管机器人骶髋固定术的成本超过开放技术，但接受机器人技术的患者报告更早恢复正常活动，术后疼痛明显减少。如果把社会成本（比如损失的工作日）也计算在内，机器人方法比开放方法更便宜。本研究的第一个目的是比较接受开放式骶髋固定术和机器人骶髋固定术的女性恢复正常活动的时间。阴道穹窿脱垂的患者将随机分为开放式或机器人腹腔骶colcol固定术。术后6周，每周使用医学结果研究生理和心理健康调查急性表（SF-12，第2版）来测量恢复正常活动的情况。接下来，将进行成本-效果分析，以比较开放式和机器人方法治疗骶髋固定术的所有成本。将通过对账单记录的具体成本分析来比较两种治疗方法之间的护理费用。将进行成本-效果分析，测量每个治疗组的成本和质量调整生命年（QALYs）。然后，我们将比较两组之间的术后疼痛，通过术后麻醉使用和视觉模拟疼痛评分来测量。还将比较机器人和开放式骶髋固定术的患者安全性，包括术中和术后即刻并发症、手术时间和出血量。本研究的最后一个目标是在术后3个月、6个月、1年和2年的体格检查和脱垂症状困扰的基础上，比较机器人和开放式骶colpop固定术的中期疗效。术前使用盆腔器官脱垂量化（POPQ）系统对盆腔器官脱垂程度进行量化。脱垂症状的困扰程度将使用盆底窘迫量表（PFDI）简短问卷进行测量。术后3个月、6个月、1年和2年，患者将使用POPQ系统再次检查复发性脱下垂，并再次给予PFDI短表。

DESCRIPTION (provided by applicant): 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.