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Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124916
First Posted: May 17, 2010
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Loyola University
May 6, 2010
May 17, 2010
November 1, 2016
January 4, 2017
January 4, 2017
November 2009
March 2013   (Final data collection date for primary outcome measure)
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.
Measure total cost of care between women who undergo laparoscopic and robotic assisted laparoscopic Abdominal Sacrocolpopexy [ Time Frame: 1 month ]
To measure the total cost of care and relate the difference in cost of care between the women undergoing laparoscopic and robotic assisted laparoscopic Abdominal Sacrocolpopexy (ASC)to differences in health utilities and health-related quality of life, which will allow us to examine the cost-effectiveness of robotic assistance.
Complete list of historical versions of study NCT01124916 on ClinicalTrials.gov Archive Site
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.
To compare short-term recovery and the time to return to normal activities between women undergoing laparoscopic and robotic assisted laparoscopic ASC. [ Time Frame: 1 year ]

1) Quality of Life

  1. Global: compare SF-36 scores and sub-scales , EQ-5D amongst groups.
  2. Disease-specific: compare urinary, bowel and prolapse scales of validated conditions specific Pelvic Floor Impact Questionnaire amongst groups.
Not Provided
Not Provided
 
Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Pelvic Organ Prolapse
  • Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy
    Robotic assisted laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
    Other Name: RASC
  • Procedure: Standard laparoscopic abdominal sacrocolpopexy
    Standard laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
    Other Name: LASC
  • Active Comparator: Laparoscopic Abdominal Sacrocolpopexy (LASC)
    Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
    Intervention: Procedure: Standard laparoscopic abdominal sacrocolpopexy
  • Experimental: Robotic Assisted Laparoscopic (RASC)
    Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
    Intervention: Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
March 2013
March 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01124916
201805
RC1EB010649-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Loyola University
Loyola University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Principal Investigator: Kimberly Kenton, M.D. Loyola University
Loyola University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP