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Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01124916
Acronym
ACCESS
Enrollment
84
Registered
2010-05-17
Start date
2009-11-30
Completion date
2013-03-31
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Keywords

incontinence, prolapse, Abdominal sacrocolpopexy

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.

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.

Interventions

PROCEDURERobotic assisted laparoscopic abdominal sacrocolpopexy

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

PROCEDUREStandard laparoscopic abdominal sacrocolpopexy

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

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
Loyola University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy6 WeeksAt 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.

Secondary

MeasureTime frameDescription
Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy6 MonthsAt 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.

Countries

United States

Participant flow

Recruitment details

The recruitment period was from November 2009 to August 2011 (21 months)

Pre-assignment details

Following enrollment, six women withdrew prior to randomization and two women were lost to follow-up prior to randomization

Participants by arm

ArmCount
Laparoscopic Abdominal Sacrocolpopexy (LASC)
Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
38
Robotic Assisted Laparoscopic (RASC)
Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
40
Total78

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up32

Baseline characteristics

CharacteristicRobotic Assisted Laparoscopic (RASC)Laparoscopic Abdominal Sacrocolpopexy (LASC)Total
Age, Continuous58.5 years
STANDARD_DEVIATION 10.5
60.6 years
STANDARD_DEVIATION 9.2
59.5 years
STANDARD_DEVIATION 9.9
Body Mass Index (BMI)28.2 kg/m^2
STANDARD_DEVIATION 6.6
27 kg/m^2
STANDARD_DEVIATION 4.7
27.7 kg/m^2
STANDARD_DEVIATION 5.7
City and state where the study activities took place
Los Angeles, California
12 Participants10 Participants22 Participants
City and state where the study activities took place
Maywood, Illinois
28 Participants28 Participants56 Participants
Comorbid Diabetes
No
34 Participants35 Participants69 Participants
Comorbid Diabetes
Yes
6 Participants3 Participants9 Participants
Concomitant estrogen therapy
No
34 Participants27 Participants61 Participants
Concomitant estrogen therapy
Yes
6 Participants11 Participants17 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants36 Participants74 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gender
Female
40 Participants38 Participants78 Participants
Gender
Male
0 Participants0 Participants0 Participants
History of Cancer
No
32 Participants32 Participants64 Participants
History of Cancer
Yes
8 Participants6 Participants14 Participants
History of Heart Attack
No
35 Participants37 Participants72 Participants
History of Heart Attack
Yes
5 Participants1 Participants6 Participants
History of Stomach Ulcer
No
30 Participants31 Participants61 Participants
History of Stomach Ulcer
Yes
10 Participants7 Participants17 Participants
History of Stroke
No
40 Participants36 Participants76 Participants
History of Stroke
Yes
0 Participants2 Participants2 Participants
Net household income
$50,000 to $75,000
11 Participants11 Participants22 Participants
Net household income
Less than $50,000
11 Participants18 Participants29 Participants
Net household income
More than $75,000
15 Participants8 Participants23 Participants
Net household income
Unknown
3 Participants1 Participants4 Participants
Parity2.6 Count of pregnancies
STANDARD_DEVIATION 1.1
2.7 Count of pregnancies
STANDARD_DEVIATION 1.3
2.7 Count of pregnancies
STANDARD_DEVIATION 1.2
Postmenopausal
No
11 Participants9 Participants20 Participants
Postmenopausal
Yes
29 Participants29 Participants58 Participants
Previous surgery for pelvic organ prolapse
No
32 Participants30 Participants62 Participants
Previous surgery for pelvic organ prolapse
Yes
8 Participants8 Participants16 Participants
Previous surgery for urinary incontinence
No
35 Participants31 Participants66 Participants
Previous surgery for urinary incontinence
Yes
5 Participants7 Participants12 Participants
Prior Hysterectomy
No
26 Participants19 Participants45 Participants
Prior Hysterectomy
Yes
14 Participants19 Participants33 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants1 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
36 Participants37 Participants73 Participants
Years of Education
12 or fewer years
14 Participants14 Participants28 Participants
Years of Education
More than 12 years
26 Participants24 Participants50 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
8 / 387 / 40
serious
Total, serious adverse events
0 / 380 / 40

Outcome results

Primary

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.

Time frame: 6 Weeks

Population: The analysis for the primary outcome includes all randomized subjects.

ArmMeasureValue (MEAN)Dispersion
Laparoscopic Abdominal Sacrocolpopexy (LASC)Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy11573 DollarsStandard Deviation 3191
Robotic Assisted Laparoscopic (RASC)Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy19616 DollarsStandard Deviation 3135
Comparison: The null hypothesis is that there is no difference in the total cost of care between standard and robotic-assisted laparoscopic abdominal sacrocolpopexy six weeks after surgery.p-value: <0.00195% CI: [7028.846, 10427.154]t-test, 2 sided
Secondary

Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy

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.

Time frame: 6 Months

Population: The analysis excludes three individuals assigned to the LASC cohort and two individuals assigned to the RASC cohort because they were lost to follow-up six months after intervention.

ArmMeasureValue (MEAN)Dispersion
Laparoscopic Abdominal Sacrocolpopexy (LASC)Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy25.1 units on a scaleStandard Deviation 31.4
Robotic Assisted Laparoscopic (RASC)Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy31.3 units on a scaleStandard Deviation 35.3
Comparison: The null hypothesis is that there is no difference in urinary distress between women assigned to LASC and those assigned to RASC six months after intervention as measured by the UDI.p-value: 0.4395% CI: [-21.769, 9.369]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026