Department of Obstetrics/Gynecology, Loyola University Chicago Stritch School of Medicine, Maywood, IL 60153 USA.
Contemp Clin Trials. 2012 Sep;33(5):1011-8. doi: 10.1016/j.cct.2012.05.007. Epub 2012 May 27.
Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches [1]. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial.
ACCESS is a randomized comparative effectiveness trial enrolling patients at two academic teaching facilities, UCLA (Los Angeles, CA) and Loyola University (Chicago, IL). The primary aim is to compare costs of robotic assisted versus pure laparoscopic abdominal sacrocolpopexy (RASC vs LASC). Following a clinical decision for minimally-invasive abdominal sacrocolpopexy (ASC) and research consent, participants with symptomatic stage≥II pelvic organ prolapse are randomized to LASC or RASC on the day of surgery. Costs of care are based on each patient's billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot and initial hospitalization and any re-hospitalization in the first 6weeks are compared between groups. Secondary outcomes include post-operative pain, anatomic outcomes, symptom severity and quality of life, and adverse events. Power calculation determined that 32 women in each arm would provide 95% power to detect a $2500 difference in total charges, using a two-sided two sample t-test with a significance level of 0.05.
Enrollment was completed in May 2011. The 12-month follow-up was completed in May 2012.
This is a multi-center study to assess cost as a primary outcome in a comparative effectiveness trial of LASC versus RASC.
机器人辅助腹腔镜手术治疗盆腔器官脱垂在美国迅速普及，尽管缺乏Ⅰ级证据支持其优于传统的开腹和腹腔镜手术方法，但仍被广泛应用[1]。本文描述了腹腔镜阴道骶骨固定术比较内镜手术策略（ACCESS）试验的设计和方法学。
ACCESS 是一项在两个学术教学机构（加利福尼亚大学洛杉矶分校[UCLA]和芝加哥洛约拉大学[Loyola University]）进行的随机对照有效性试验。主要目的是比较机器人辅助与单纯腹腔镜经腹阴道骶骨固定术（RASC 与 LASC）的成本。在临床决定采用微创经腹阴道骶骨固定术（ASC）和获得研究同意后，对于有症状的Ⅱ期及以上盆腔器官脱垂的患者，在手术当天根据随机分组接受 LASC 或 RASC。根据每个患者的计费记录和每个医院的设备成本来计算医疗费用。比较两组之间与手术相关的所有费用，包括机器人相关费用、初始住院费用以及术后 6 周内的任何再次住院费用。次要结局包括术后疼痛、解剖学结果、症状严重程度和生活质量以及不良事件。根据统计分析，需要每组 32 例患者才能达到检测总费用 2500 美元差异的 95%效力，采用双侧两样本 t 检验，显著性水平为 0.05。
该试验于 2011 年 5 月完成入组，2012 年 5 月完成 12 个月的随访。
这是一项多中心研究，旨在评估 LASC 与 RASC 比较有效性试验的成本作为主要结局。
