Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS)

November 1, 2016 updated by: Loyola University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately one in ten women undergoes surgery for prolapse or incontinence in her lifetime. Of these, up to thirty percent require a re-operation for recurrence of their prolapse or incontinence symptoms. It has been estimated one in nine women will undergo a hysterectomy in her lifetime, and up to 10% of these women will require surgery for symptomatic vaginal vault prolapse. The search for the ideal repair for pelvic organ prolapse has led to the invention of several approaches to this problem.

Abdominal sacrocolpopexy (ASC) with synthetic mesh is considered the gold standard in the surgical management of pelvic organ prolapse with anatomic success rates ranging from 90 to 100%. Randomized comparative effectiveness trials and systematic literature reviews demonstrated the anatomic superiority of open ASC compared to vaginal sacrospinous ligament suspension.

Although ASC has the highest anatomic success rates for correcting apical prolapse, it is traditionally done via a laparotomy requiring an abdominal incision. Open technique is associated with more frequent short-term complications, including gastrointestinal.

Minimally invasive approaches to ASC using laparoscopy or robotic assisted laparoscopy demonstrate shorter hospital stays, decreased blood loss, and similar short-term anatomic outcomes when compared to open ASC. Increasing numbers of surgeons and patients choose minimally invasive ASC to maximize the benefits of abdominal placed mesh and the shorter-recovery associated with minimally invasive surgery. Few studies have compared laparoscopy to robotic assisted-laparoscopy in pelvic reconstructive surgery.

Like many techniques in pelvic surgery, trends in the management of pelvic organ prolapse continue to evolve. Unfortunately, such trends are not supported by robust data, specifically that provided by randomized clinical trials. Although robotic technology is new and rapidly spreading throughout the urologic and gynecologic communities, there are no randomized trials comparing outcomes of robotic to more traditional laparoscopic techniques for reconstructive pelvic surgery. Retrospective series indicate comparable efficacy with respect to cure of prolapse. However, to date is it unknown how robotic surgery compares to laparoscopic techniques with respect to cost, patient safety, pain, and ability to return to normal activities.

The use of the robot in laparoscopic surgery is costly. The costs of purchasing a robot has been estimated at $1.5 million dollars with annual maintenance costs of $112,0007. In addition, additional costs exist for the robotic equipment utilized with each case. It is arguable that the maintenance and operative equipment costs may overshadow any potential savings in length of hospital stay and patient convalescence. However, if robotic sacrocolpopexy can provide better immediate quality of life, less pain, and faster recovery compared to laparoscopic techniques, the investment in robotic techniques may very well be cost effective when a societal perspective is taken.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Stage II to IV pelvic organ prolapse
  2. Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal
  3. Vaginal bulge symptoms
  4. Minimally invasive surgery is planned
  5. Available for 12 months of follow-up
  6. Able to complete study assessments
  7. Able and willing to provide written informed consent

Exclusion Criteria:

  1. Contraindication to laparoscopic or robotically assisted laparoscopic abdominal sacrocolpopexy
  2. Subject wishes to retain her uterus (i.e., surgical assignment may involve removal of uterus, if not previously removed)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Laparoscopic Abdominal Sacrocolpopexy (LASC)
Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
Procedure: Standard laparoscopic abdominal sacrocolpopexy
Standard laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
Other Names:
  • LASC
EXPERIMENTAL: Robotic Assisted Laparoscopic (RASC)
Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy
Robotic assisted laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
Other Names:
  • RASC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
Time Frame: 6 Weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
Time Frame: 6 Months
At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

  • Principal Investigator: Kimberly Kenton, M.D., Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 16, 2010

First Posted (ESTIMATE)

May 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2017

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201805
  • RC1EB010649-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Organ Prolapse

Clinical Trials on Standard laparoscopic abdominal sacrocolpopexy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe