Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS)

Abstract

Introduction 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. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial [1]. Methods 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 6 weeks 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. Results Enrollment was completed in May 2011. The 12-month follow-up will end in May 2012. Conclusions This is a multi-center study to assess cost as a primary outcome in a comparative effectiveness trial of LASC versus RASC.

Robotic Compared With Laparoscopic Sacrocolpopexy

“…The primary aim was to compare costs of robotic and laparoscopic. Detailed methods are described in a separate article by Mueller et al (4). Entry criteria included a clinical indication for sacrocolpopexy in women with symptomatic stage II or greater pelvic organ prolapse (POP), with the leading edge of the prolapse to 1 cm on either side of the introitus, including apical support loss to ½ total vaginal length (the top of the vagina or cervix descending down at least halfway down the vaginal canal).…”

“…Surgeons were required to have performed at least 10 procedures of each type prior to study participation. Sacrocolpopexy was performed with two separate pieces of synthetic mesh (vs. Y-shaped mesh) and Gore-Tex sutures (4). Surgeon preference determined the brand of mesh used and whether the retroperitoneal lining was re-approximated after mesh tensioning.…”

“…Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events (AE). A priori power calculation determined that 32 women in each arm would provide 95% power to detect a difference of at least $2,500 difference in total charges, using a 2-sided t-test with a 0.05 significance level and standard deviations similar to previously published work (4,5). Additional patients would be recruited until the end of the study period to account for any loss to follow-up.…”

Abdominal approaches to pelvic prolapse repairs

“…In a randomized trial comparing costs of laparoscopic and robotic sacrocolpopexy, the day of surgery hospital costs were significantly higher for robotic patients ($19 616 vs. $11 573; P <0.001) and remained higher at the 6-week follow-up visit ($20 898 vs. $12 170; P ¼ <0.001) [32]. However, when excluding the cost of the robotic unit and the yearly maintenance, costs were similar for both the robotic and laparoscopic approaches [33].…”

Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial

“…The Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial was a two-center randomized comparative trial conducted at UCLA and Loyola University Medical Center (Chicago, IL)(3,6). IRB approval for this study was obtained at each site.…”