CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Robotic assisted laparoscopic abdominal sacrocolpopexy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01124916
NCT01124916N/ACompleted

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Loyola University·interventional·Posted May 17, 2010·Updated Jan 4, 2017

In Brief

A clinical study evaluating Robotic assisted laparoscopic abdominal sacrocolpopexy and Standard laparoscopic abdominal sacrocolpopexy for Pelvic Organ Prolapse. Completed, enrolled 84 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2010
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.1 years ago

Interventions

Robotic assisted laparoscopic abdominal sacrocolpopexyprocedure

Robotic assisted laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.

Standard laparoscopic abdominal sacrocolpopexyprocedure

Standard laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.