Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT01124916

Run by

Loyola University

People needed

84

Starts

2009-11-01

Expected to finish

2013-03-01

Last updated by the study team

2017-01-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stage II to IV pelvic organ prolapse
• Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal
• Vaginal bulge symptoms
• Minimally invasive surgery is planned
• Available for 12 months of follow-up
• Able to complete study assessments
• Able and willing to provide written informed consent

You may not qualify if…

• Contraindication to laparoscopic or robotically assisted laparoscopic abdominal sacrocolpopexy
• Subject wishes to retain her uterus (i.e., surgical assignment may involve removal of uterus, if not previously removed)

Where it is running

• UCLA — Los Angeles, California, United States
• Loyola University Medical Center — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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