Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Pelvic Organ Prolapse Clinical Trial

— ACCESS  

Official title:

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01124916
• Other study ID #: 201805
• Secondary ID: RC1EB010649-01
• Status: Active, not recruiting
• Phase: N/A
• First received: May 6, 2010
• Last updated: October 29, 2012
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: October 2012
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. Thje investigators don't know if the decision to use robotic assistance at the time of laparoscopic sacrocolpopexy is a benefit for the patient. The investigators will compare the outcomes of cost, quality of life, and return to work for 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 investigators also will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.

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% (Brubaker L, Guiahi M). 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 (Benson JT, Whitehead W).

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 (Geller E, Tarr M, Paiso M). Increasing numbers of surgeons and patients choose minimally invasive ASC to maximize the benefits of abdominally 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 level I 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 (POP-Q point C > -TVL/2)

3. Vaginal bulge symptoms as indicated by an affirmative response to either question 4 or 5 of the PFDI;

• Do you usually have the sensation of a bulging or protrusion from the vaginal area?

• Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?

4. Minimally invasive ASC is planned

5. Available for 12 months of follow-up

6. Able to complete study assessments, per clinician judgment

7. Able and willing to provide written informed consent

Exclusion Criteria:

1. Contraindication to laparoscopic or robotically assisted laparoscopic ASC in the opinion of the treating surgeon

2. Subject wished to retain her uterus (ASC requires removal of uterus, if not previously removed)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Robotic Assisted Laparoscopic ASC
robotic assisted laparoscopy for surgical repair of pelvic organ prolapse.
• Laparoscopic Abdominal Sacrocolpopexy
Laparoscopic repair of pelvic organ prolapse

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure total cost of care between women who undergo laparoscopic and robotic assisted laparoscopic Abdominal Sacrocolpopexy	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.	1 month	No
Secondary	To compare short-term recovery and the time to return to normal activities between women undergoing laparoscopic and robotic assisted laparoscopic ASC.	1) Quality of Life; Global: compare SF-36 scores and sub-scales , EQ-5D amongst groups.; Disease-specific: compare urinary, bowel and prolapse scales of validated conditions specific Pelvic Floor Impact Questionnaire amongst groups.	1 year	No