Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach
|ClinicalTrials.gov Identifier: NCT01611285|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : June 9, 2017
|Condition or disease|
|Pelvic Organ Prolapse|
The cumulative incidence of pelvic organ prolapse was approximately 2% in 2001. Given the aging demographics in the U.S., the incidence of prolapse is projected to increase to 30% or more for women aged 60 years and older and become of greater concern to both patients and physicians. The demand for gynecologic services is predicted to increase by more than 45% in the next ten years. Prolapse is related to childbirth, aging, defects in collagen, and smooth muscle structure and strength. Etiology includes intra-abdominal pressure from obesity, with obesity becoming an ever increasing factor in the US.
Treatment Choice of Patients:
Patients choose between pessary, surgery, and expectant management based on: age, prior prolapse surgery, preoperative pelvic pain scores, and pelvic organ prolapse severity. These are difficult decisions for patients.
When it comes to choosing between destinctive interventions with subtle advantages and disadvantages, patients typically want to hear their physician's views of the scientific merits of each procedure. Informed consent becomes extremely difficult when issues of cost-effectiveness are at hand. Thus, the proposed project.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Uphold Versus Robotic Surgery for Pelvic Prolapse Repair: A Decision Analytic Approach|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||August 2011|
Robotic Sacrocolpopexy patients
Patients who underwent Robotic Sacrocolpopexy to treat pelvic organ prolapse between 2009 and 2010
Patients who underwent the UPHOLD procedure to treat pelvic organ prolapse from 2009-2010.
- Surgical cure versus failure of prolapse repair [ Time Frame: within 12 months of patients surgery ]Incidence of recurrance of pelvic organ prolapse within 12 months of either robotic sacrocolpopexy or the UPHOLD procedure
- Financial costs of outcomes [ Time Frame: within 12 months of patients surgery ]Financial costs that will incur to produce the primary outcomes- success or failure. When the two outcomes are considered together, we have "cost effectiveness"
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611285
|United States, New Jersey|
|Atlantic Health System Department of Urogynecology|
|Morristown, New Jersey, United States, 07960|
|Principal Investigator:||Patrick Culligan, MD FACOG FACS||Atlantic Health System|