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NCT01124916 · ClinicalTrials.gov registry record · NA
Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
A NA study of Pelvic Organ Prolapse, sponsored by Loyola University.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
- 2
- Study locations
NCT01124916: Completed NA study of Pelvic Organ Prolapse, sponsored by Loyola University.
NCT01124916 is a NA study of Pelvic Organ Prolapse that has completed, run by Loyola University. The registered enrollment target is 84 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124916, a NA study of Pelvic Organ Prolapse, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy.
Conditions Studied
Interventions
- PROCEDURE Robotic assisted laparoscopic abdominal sacrocolpopexy
- PROCEDURE Standard laparoscopic abdominal sacrocolpopexy
Study Locations (2)
California
- UCLA - Los Angeles
Illinois
- Loyola University Medical Center - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2009-11 |
| Est. Completion | 2013-03 |
| Phase | NA |
What the finished NCT01124916 record still lists
NCT01124916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Robotic assisted laparoscopic abdominal sacrocolpopexy is the first listed.
NCT01124916 reports a single indexed study location in California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01124916 about?
NCT01124916 is a clinical study titled "Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies". 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 robo...
What is the current status of trial NCT01124916?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2009-11. Estimated completion is 2013-03.
What conditions does trial NCT01124916 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse.
What interventions are being tested in trial NCT01124916?
The interventions under investigation include: Robotic assisted laparoscopic abdominal sacrocolpopexy (PROCEDURE), Standard laparoscopic abdominal sacrocolpopexy (PROCEDURE).
Who is sponsoring clinical trial NCT01124916?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01124916 being conducted?
This trial has 2 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01124916's enrollment target sits among peer trials
84 25th of 40 higher than 16 of 40 other Pelvic Organ Prolapse trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pelvic Organ Prolapse trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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