Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
Information source: University of California, Irvine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pelvic Organ Prolapse
Phase: N/A
Status: Completed
Sponsored by: University of California, Irvine Official(s) and/or principal investigator(s): Karen L Noblett, M.D., Principal Investigator, Affiliation: University of California, Irvine
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.
Clinical Details
Official title: Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates
Study design: Observational Model: Case-Only, Time Perspective: Retrospective
Primary outcome: The erosion rates of composite biologic/syntheric grafts and synthetic-only grafts will be compared.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients who underwent abdominal sacrocolpopexy with Drs. Noblett and Lane from 2001
to present
Exclusion Criteria:
- None
Locations and Contacts
University of California, Irvine Medical Center, Orange, California 92868, United States
Additional Information
Starting date: September 2007
Last updated: January 7, 2010
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