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Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

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ClinicalTrials.gov Identifier: NCT00581412
Recruitment Status : Completed
First Posted : December 27, 2007
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
University of California, Irvine

Brief Summary:
This study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.

Condition or disease
Pelvic Organ Prolapse

Detailed Description:
This study will examine the erosion rate of a composite graft that is being used during abdominal sacrocolpopexy. The composite graft is composed of a dual layer of biological and syntheric material. Biological grafts have the advantage of significantly reducing erosion rates, but the longevity of biologic graft is uncertain. On the other hand, synthetic grafts have the advantage in that they are durable, but have higher erosion rates through the vagina and require re-operation in a small percentage of patients. This study will look at whether or not the use of a composite greaft carries the advantages of both types of materials and leads to decreased rates of erosion while maintaining longevity. The cost effectiveness of this new type of graft will also be reviewed since the disavantage of utilizing both the synthetic and biologic graft is that it will increase the cost.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
Study Start Date : September 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

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U.S. FDA Resources




Primary Outcome Measures :
  1. The erosion rates of composite biologic/syntheric grafts and synthetic-only grafts will be compared. [ Time Frame: To the point of graft erosion after abdominal sacrocolpopexy ]

Secondary Outcome Measures :
  1. Cost effectiveness will be examined by comparing the price of a composite graft to the cost of re-operation due to erosion of a synthetic-only graft. [ Time Frame: To the point of graft erosion after abdominal sacrocolpopexy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent abdominal sacrocolpopexy
Criteria

Inclusion Criteria:

  • Patients who underwent abdominal sacrocolpopexy with Drs. Noblett and Lane from 2001 to present

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581412


Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Karen L Noblett, M.D. University of California, Irvine

Responsible Party: Karen Noblett, Associate Professor, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00581412     History of Changes
Other Study ID Numbers: 2007-5858
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: January 11, 2010
Last Verified: January 2010

Keywords provided by University of California, Irvine:
Pelvic organ prolapse
Composite biologic/synthetic graft
Abdominal sacrocolpopexy

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical