Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS).
BACKGROUND
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.


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 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.


RESULTS
Enrollment was completed in May 2011. The 12-month follow-up was completed 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.
Department of Obstetrics/Gynecology, Loyola University Chicago Stritch School of Medicine, Maywood, IL 60153 USA. emuelle@lumc.edu
E R
ER
Mueller
K
K
Kenton
C
C
Tarnay
L
L
Brubaker
A
A
Rosenman
B
B
Smith
K
K
Stroupe
C
C
Bresee
A
A
Pantuck
P
P
Schulam
J T
JT
Anger
D003127:Colposcopy / Q000191:economics / Q000379:methods*; D057186:Comparative Effectiveness Research / Q000379:methods*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000191:economics / Q000379:methods*; D015337:Multicenter Studies as Topic / Q000379:methods; D011183:Postoperative Complications; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012371:Robotics / Q000191:economics / Q000379:methods*; D016037:Single-Blind Method; D014596:Uterine Prolapse / Q000601:surgery*