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Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00581412
First received: December 20, 2007
Last updated: January 7, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 20, 2007
Last Updated: January 7, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013