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ACCESS: Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies

Sponsor
Loyola University (Other)
Overall Status
Completed
CT.gov ID
NCT01124916
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB) (NIH)
84
Enrollment
2
Locations
2
Arms
40
Duration (Months)
42
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy
  • Procedure: Standard laparoscopic abdominal sacrocolpopexy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
Study Start Date :
Nov 1, 2009
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy [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.

    Secondary Outcome Measures

    1. Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Los Angeles California United States 90095
    2 Loyola University Medical Center Maywood Illinois United States 60153

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Loyola University
    ClinicalTrials.gov Identifier:
    NCT01124916
    Other Study ID Numbers:
    • 201805
    • RC1EB010649-01
    First Posted:
    May 17, 2010
    Last Update Posted:
    Jan 4, 2017
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Loyola University
    incontinence
    prolapse
    Abdominal sacrocolpopexy
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    Participant Flow

    Recruitment Details The recruitment period was from November 2009 to August 2011 (21 months)
    Pre-assignment Detail Following enrollment, six women withdrew prior to randomization and two women were lost to follow-up prior to randomization
    Arm/Group Title Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC)
    Arm/Group Description Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
    Period Title: Overall Study
    STARTED 38 40
    COMPLETED 35 38
    NOT COMPLETED 3 2

    Baseline Characteristics

    Arm/Group Title Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC) Total
    Arm/Group Description Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC) Total of all reporting groups
    Overall Participants 38 40 78
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60.6
    (9.2)
    58.5
    (10.5)
    59.5
    (9.9)
    Gender (Count of Participants)
    Female
    38
    100%
    40
    100%
    78
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    5.3%
    2
    5%
    4
    5.1%
    Not Hispanic or Latino
    36
    94.7%
    38
    95%
    74
    94.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    2.6%
    4
    10%
    5
    6.4%
    White
    37
    97.4%
    36
    90%
    73
    93.6%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    City and state where the study activities took place (Count of Participants)
    Maywood, Illinois
    28
    73.7%
    28
    70%
    56
    71.8%
    Los Angeles, California
    10
    26.3%
    12
    30%
    22
    28.2%
    Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    27
    (4.7)
    28.2
    (6.6)
    27.7
    (5.7)
    Parity (Count of pregnancies) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Count of pregnancies]
    2.7
    (1.3)
    2.6
    (1.1)
    2.7
    (1.2)
    Years of Education (Count of Participants)
    12 or fewer years
    14
    36.8%
    14
    35%
    28
    35.9%
    More than 12 years
    24
    63.2%
    26
    65%
    50
    64.1%
    Net household income (Count of Participants)
    Less than $50,000
    18
    47.4%
    11
    27.5%
    29
    37.2%
    $50,000 to $75,000
    11
    28.9%
    11
    27.5%
    22
    28.2%
    More than $75,000
    8
    21.1%
    15
    37.5%
    23
    29.5%
    Unknown
    1
    2.6%
    3
    7.5%
    4
    5.1%
    Comorbid Diabetes (Count of Participants)
    No
    35
    92.1%
    34
    85%
    69
    88.5%
    Yes
    3
    7.9%
    6
    15%
    9
    11.5%
    History of Heart Attack (Count of Participants)
    No
    37
    97.4%
    35
    87.5%
    72
    92.3%
    Yes
    1
    2.6%
    5
    12.5%
    6
    7.7%
    History of Stroke (Count of Participants)
    No
    36
    94.7%
    40
    100%
    76
    97.4%
    Yes
    2
    5.3%
    0
    0%
    2
    2.6%
    History of Cancer (Count of Participants)
    No
    32
    84.2%
    32
    80%
    64
    82.1%
    Yes
    6
    15.8%
    8
    20%
    14
    17.9%
    History of Stomach Ulcer (Count of Participants)
    No
    31
    81.6%
    30
    75%
    61
    78.2%
    Yes
    7
    18.4%
    10
    25%
    17
    21.8%
    Postmenopausal (Count of Participants)
    No
    9
    23.7%
    11
    27.5%
    20
    25.6%
    Yes
    29
    76.3%
    29
    72.5%
    58
    74.4%
    Concomitant estrogen therapy (Count of Participants)
    No
    27
    71.1%
    34
    85%
    61
    78.2%
    Yes
    11
    28.9%
    6
    15%
    17
    21.8%
    Previous surgery for urinary incontinence (Count of Participants)
    No
    31
    81.6%
    35
    87.5%
    66
    84.6%
    Yes
    7
    18.4%
    5
    12.5%
    12
    15.4%
    Previous surgery for pelvic organ prolapse (Count of Participants)
    No
    30
    78.9%
    32
    80%
    62
    79.5%
    Yes
    8
    21.1%
    8
    20%
    16
    20.5%
    Prior Hysterectomy (Count of Participants)
    No
    19
    50%
    26
    65%
    45
    57.7%
    Yes
    19
    50%
    14
    35%
    33
    42.3%

    Outcome Measures

    1. Primary Outcome
    Title Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
    Description 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

    Outcome Measure Data

    Analysis Population Description
    The analysis for the primary outcome includes all randomized subjects.
    Arm/Group Title Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC)
    Arm/Group Description Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
    Measure Participants 38 40
    Mean (Standard Deviation) [Dollars]
    11573
    (3191)
    19616
    (3135)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Laparoscopic Abdominal Sacrocolpopexy (LASC), Robotic Assisted Laparoscopic (RASC)
    Comments 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.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.001
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 8728
    Confidence Interval (2-Sided) 95%
    7028.846 to 10427.154
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 853.129
    Estimation Comments
    2. Secondary Outcome
    Title Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC)
    Arm/Group Description Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
    Measure Participants 35 38
    Mean (Standard Deviation) [units on a scale]
    25.1
    (31.4)
    31.3
    (35.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Laparoscopic Abdominal Sacrocolpopexy (LASC), Robotic Assisted Laparoscopic (RASC)
    Comments 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.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value .43
    Comments
    Method t-test, 2 sided
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 6.20
    Confidence Interval (2-Sided) 95%
    -21.769 to 9.369
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.846
    Estimation Comments

    Adverse Events

    Time Frame Adverse event data were collected for 1 year, 9 months
    Adverse Event Reporting Description
    Arm/Group Title Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC)
    Arm/Group Description Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
    All Cause Mortality
    Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/38 (0%) 0/40 (0%)
    Other (Not Including Serious) Adverse Events
    Laparoscopic Abdominal Sacrocolpopexy (LASC) Robotic Assisted Laparoscopic (RASC)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/38 (21.1%) 7/40 (17.5%)
    Cardiac disorders
    Atrial fibrillation 1/38 (2.6%) 1 0/40 (0%) 0
    Gastrointestinal disorders
    Diverticulitis 0/38 (0%) 0 1/40 (2.5%) 1
    Incarcerated Hernia 1/38 (2.6%) 1 1/40 (2.5%) 1
    Mallory-Weiss tear 1/38 (2.6%) 1 0/40 (0%) 0
    Bowel obstruction 1/38 (2.6%) 1 0/40 (0%) 0
    General disorders
    Dyspnea 0/38 (0%) 0 1/40 (2.5%) 1
    Reproductive system and breast disorders
    Tissue granulation 3/38 (7.9%) 4 0/40 (0%) 0
    Surgical and medical procedures
    Mesh Exposure 0/38 (0%) 0 3/40 (7.5%) 3
    Illiac Vein Injury 1/38 (2.6%) 1 1/40 (2.5%) 1
    Intraoperative cystotomy 1/38 (2.6%) 1 1/40 (2.5%) 1

    Limitations/Caveats

    There are no limitations or caveats to specify.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Elizabeth Mueller, M.D.
    Organization Loyola University
    Phone 708-216-2180
    Email emuelle@lumc.edu
    Responsible Party:
    Loyola University
    ClinicalTrials.gov Identifier:
    NCT01124916
    Other Study ID Numbers:
    • 201805
    • RC1EB010649-01
    First Posted:
    May 17, 2010
    Last Update Posted:
    Jan 4, 2017
    Last Verified:
    Nov 1, 2016