Increasing the Utility of Contrast Agents for MRI

描述(由申请者提供)：本申请回应了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)，被处理。与标准的腹式固定术相比，微创机器人固定术是治疗阴道根尖脱垂的经典金标准手术，具有提供更安全、更精确的治疗方法的潜力，且患者发病率较低。这项研究的总体目标是比较机器人和传统开放手术的结果，重点是恢复活动的时间、患者的安全性、疼痛评分和成本。我们假设，尽管机器人骶椎固定术的成本高于开放技术，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。如果将社会成本(如损失的工作日)也包括在内，机器人方法比开放式方法更便宜。这项研究的第一个目的是比较接受开放式和机器人固定术的女性恢复正常活动的时间。阴道穹隆脱垂的患者将随机接受开放式或机械式腹部固定术。恢复正常活动将使用医疗结果研究身体和精神健康调查急性表格(SF-12，版本2)进行测量，手术后6周每周提供一次。下一步，将进行成本效益分析，以比较开放和机器人固定术的所有成本。护理费用将通过对账单记录的具体成本分析来比较两个治疗部门之间的费用。将进行成本效益分析，以衡量每个治疗臂的成本和质量调整寿命年(QALY)。然后，我们将比较两组之间的术后疼痛，通过术后麻醉剂使用和视觉模拟疼痛评分来衡量。还将比较机器人和开放固定术之间的患者安全性，包括术中和术后的即时并发症、手术时间和出血量。这项研究的最后目标是比较机器人和开放式固定术的中期疗效，基于术后三个月、六个月、一年和两年的体检和脱垂症状。盆腔器官脱垂的程度将在术前用盆腔器官脱垂量化(POPQ)系统进行量化。脱垂症状的困扰程度将使用盆底窘迫问卷(PFDI)短式问卷来衡量。在术后三个月、六个月、一年和两年时，患者将使用POPQ系统重新检查是否有复发的脱垂，并将再次获得PFDI缩写。 与公共卫生相关：尽管机器人技术是一项新技术，并在整个泌尿外科和妇科社区迅速传播，但还没有随机试验比较机器人和开放式固定术治疗阴道脱垂的结果。这项研究的主要目的是比较机器人和开放式固定术在患者康复方面的短期结果。次要目标将包括通过成本效益分析直接比较患者的安全性、成本和术后疼痛。

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.