Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

NCT01124916 | Completed Results DMC

• 2 other identifiers: 201805RC1EB010649-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

incontinence; prolapse; Abdominal sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

• Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy

  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.

  6 Weeks

Secondary Outcomes (1)

• Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy

  6 Months

Study Arms (2)

Laparoscopic Abdominal Sacrocolpopexy (LASC)

ACTIVE COMPARATOR

Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)

Procedure: Standard laparoscopic abdominal sacrocolpopexy

Robotic Assisted Laparoscopic (RASC)

EXPERIMENTAL

Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)

Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy

Interventions

Robotic assisted laparoscopic abdominal sacrocolpopexy PROCEDURE

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

Also known as: RASC

Robotic Assisted Laparoscopic (RASC)

Standard laparoscopic abdominal sacrocolpopexy PROCEDURE

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

Also known as: LASC

Laparoscopic Abdominal Sacrocolpopexy (LASC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loyola University: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (2)

UCLA

Los Angeles, California, 90095, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (27)

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• Kenton K, Mueller ER, Tarney C, Bresee C, Anger JT. One-Year Outcomes After Minimally Invasive Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):382-4. doi: 10.1097/SPV.0000000000000300.

  PMID: 27403758 DERIVED

• Mueller ER, Kenton K, Anger JT, Bresee C, Tarnay C. Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):917-21. doi: 10.1016/j.jmig.2016.05.001. Epub 2016 May 12.

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• Anger JT, Mueller ER, Tarnay C, Smith B, Stroupe K, Rosenman A, Brubaker L, Bresee C, Kenton K. Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):5-12. doi: 10.1097/AOG.0000000000000006.

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MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

There are no limitations or caveats to specify.

Results Point of Contact

• Title: Elizabeth Mueller, M.D.
• Organization: Loyola University

emuelle@lumc.edu

708-216-2180

Study Officials

• Kimberly Kenton, M.D.

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 17, 2010
• Study Start: November 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)