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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

Page last updated: August 23, 2015

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