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Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

NCT01124916 · Loyola University · Updated 4 Jan 2017

What is being tested
Robotic assisted laparoscopic abdominal sacrocolpopexy; Standard laparoscopic abdominal sacrocolpopexy
For
Pelvic Organ Prolapse
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 84 people. The full rules are on the registry page.
Where
United States (2 sites)
When
Starts or started Nov 2009, ends March 2013. Registered 17 May 2010.
Results
Posted on the registry on 4 Jan 2017.

In the researchers' words

The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot. Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques. This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.
ClinicalTrials.gov, NCT01124916

Sites

  • UCLALos Angeles, California, United States
  • Loyola University Medical CenterMaywood, Illinois, United States