Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS)

This study has been completed.
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01124916
First received: May 6, 2010
Last updated: November 1, 2016
Last verified: November 2016
Results First Received: November 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pelvic Organ Prolapse
Interventions: Procedure: Robotic assisted laparoscopic abdominal sacrocolpopexy
Procedure: Standard laparoscopic abdominal sacrocolpopexy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from November 2009 to August 2011 (21 months)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following enrollment, six women withdrew prior to randomization and two women were lost to follow-up prior to randomization

Reporting Groups
  Description
Laparoscopic Abdominal Sacrocolpopexy (LASC) Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
Robotic Assisted Laparoscopic (RASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)

Participant Flow:   Overall Study
    Laparoscopic Abdominal Sacrocolpopexy (LASC)   Robotic Assisted Laparoscopic (RASC)
STARTED   38   40 
COMPLETED   35   38 
NOT COMPLETED   3   2 
Lost to Follow-up                3                2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline analysis population comprises all randomized subjects

Reporting Groups
  Description
Laparoscopic Abdominal Sacrocolpopexy (LASC) Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
Robotic Assisted Laparoscopic (RASC) Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
Total Total of all reporting groups

Baseline Measures
   Laparoscopic Abdominal Sacrocolpopexy (LASC)   Robotic Assisted Laparoscopic (RASC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   40   78 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.6  (9.2)   58.5  (10.5)   59.5  (9.9) 
Gender 
[Units: Participants]
Count of Participants
     
Female      38 100.0%      40 100.0%      78 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   5.3%      2   5.0%      4   5.1% 
Not Hispanic or Latino      36  94.7%      38  95.0%      74  94.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   2.6%      4  10.0%      5   6.4% 
White      37  97.4%      36  90.0%      73  93.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
City and state where the study activities took place 
[Units: Participants]
Count of Participants
     
Maywood, Illinois      28  73.7%      28  70.0%      56  71.8% 
Los Angeles, California      10  26.3%      12  30.0%      22  28.2% 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 27  (4.7)   28.2  (6.6)   27.7  (5.7) 
Parity 
[Units: Count of pregnancies]
Mean (Standard Deviation)
 2.7  (1.3)   2.6  (1.1)   2.7  (1.2) 
Years of Education 
[Units: Participants]
Count of Participants
     
12 or fewer years      14  36.8%      14  35.0%      28  35.9% 
More than 12 years      24  63.2%      26  65.0%      50  64.1% 
Net household income 
[Units: Participants]
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 
[Units: Participants]
Count of Participants
     
No      35  92.1%      34  85.0%      69  88.5% 
Yes      3   7.9%      6  15.0%      9  11.5% 
History of Heart Attack 
[Units: Participants]
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 
[Units: Participants]
Count of Participants
     
No      36  94.7%      40 100.0%      76  97.4% 
Yes      2   5.3%      0   0.0%      2   2.6% 
History of Cancer 
[Units: Participants]
Count of Participants
     
No      32  84.2%      32  80.0%      64  82.1% 
Yes      6  15.8%      8  20.0%      14  17.9% 
History of Stomach Ulcer 
[Units: Participants]
Count of Participants
     
No      31  81.6%      30  75.0%      61  78.2% 
Yes      7  18.4%      10  25.0%      17  21.8% 
Postmenopausal 
[Units: Participants]
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 
[Units: Participants]
Count of Participants
     
No      27  71.1%      34  85.0%      61  78.2% 
Yes      11  28.9%      6  15.0%      17  21.8% 
Previous surgery for urinary incontinence 
[Units: Participants]
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 
[Units: Participants]
Count of Participants
     
No      30  78.9%      32  80.0%      62  79.5% 
Yes      8  21.1%      8  20.0%      16  20.5% 
Prior Hysterectomy 
[Units: Participants]
Count of Participants
     
No      19  50.0%      26  65.0%      45  57.7% 
Yes      19  50.0%      14  35.0%      33  42.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy   [ Time Frame: 6 Weeks ]

2.  Secondary:   Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy   [ Time Frame: 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There are no limitations or caveats to specify.


  More Information
  Hide 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
e-mail: emuelle@lumc.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01124916     History of Changes
Other Study ID Numbers: 201805
RC1EB010649-01 ( US NIH Grant/Contract Award Number )
Study First Received: May 6, 2010
Results First Received: November 1, 2016
Last Updated: November 1, 2016
Health Authority: United States: Institutional Review Board