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

Authors: Mueller, E. R.; Kenton, K.; Tarnay, C.; Brubaker, L; Rosenman, A.; Smith, B; Stroupe, K; Bresee, C.; Pantuck, A.; Schulam, P.; Anger, J. T.
Article Title: 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 [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. Copyright 2012 Elsevier Inc. All rights reserved.
Journal Title: Contemporary clinical trials
Volume: 33
Issue: 5
ISSN: 1559-2030; 1551-7144
Publisher: Elsevier Inc  
Journal Place: United States
Date Published: 2012
Start Page: 1011
End Page: 1018
Language: English
Notes: ID: 12647; Status: MEDLINE; Publishing Model: Journal available in: Print-Electronic Citation processed from: Internet; NLM Journal Code: 101242342; Grant Number: 1 RC1 EB010649-01 (United States NIBIB NIH HHS)
LUC Authors
  1. Linda Brubaker
    144 Brubaker
  2. Kevin Todd Stroupe
    46 Stroupe
  3. Elizabeth Mueller
    104 Mueller