MedTrace Logo

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

NCT01124916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-01-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Robotic assisted laparoscopic abdominal sacrocolpopexy

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

PROCEDURE

Standard laparoscopic abdominal sacrocolpopexy

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

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Loyola University

    lead OTHER

Principal Investigators

  • Kimberly Kenton, M.D. · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124916 on ClinicalTrials.gov