N/A N=78 Randomized Double-blind Treatment

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Pelvic Organ Prolapse

Bottom Line

View on ClinicalTrials.gov: NCT01124916 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy — 11573; 19616 Dollars — p=<.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robotic assisted laparoscopic abdominal sacrocolpopexy (Procedure); Standard laparoscopic abdominal sacrocolpopexy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Loyola University
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy	11573; 19616	<.001 sig
SECONDARY Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy	25.1; 31.3	.43

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

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Data sourced from ClinicalTrials.gov (NCT01124916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.